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Rosa Prince, I’ll also be with you on Tuesday.
IT IS NOT EASY TO BE A PM:Rishi hasn’t been having the best of days with predictions that his by-election campaign would be wiped out, his NHS plan being overshadowed and Daniel Korski self-defenestration, plus last week’s Rwanda Scheme court blow. Today, a group red wall Tory members publishes a “alternative” manifesto to cut immigration. The Sun describes this as a “fresh attack on the prime minister’s authority.”
With Friends Like These:Most papers agree that the plan drafted by the New Conservatives Group of Tory MPs re-elected in 2017 and 2019 poses a direct threat to the PM. The group wants the government to fulfill its manifesto promise to reduce net migration to below 226,000 before the next election to “save faces” and maintain voter trust. Party Vice Chairman Lee Anderson, among other MPs, has backed their 12-point plan.
The planProposals are to increase salary thresholds for immigrant workers, limit visas for care workers, stop foreign students from staying after they graduate, and tighten language requirements. Tom Hunt, Ipswich’s MP, was one of the authors of the plan. He explained its motivation on BBC Radio 4’s Westminster Hour: “When I knock at doors and talk to constituents about immigration, it is a major issue that keeps coming up.”
Suella boost The Times reports that the demands have the effect of bolstering the Home Secretary Suella in her internal arguments against Chancellor Jeremy Hunt, and Education Secretary Gillian Keegan. They are concerned that restricting immigration would harm the economy and lucrative university sector.
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Baker and Braverman Less fortunately for the home secretary, the Mail and Guardian were both informed that former supporter Steve Baker turned against Braverman after her suggestion that there was a “predominance of British-Pakistani males involved with sexually abuse grooming gangs. Baker’s Wycombe Constituency has a large proportion of Asian voters and he will defend just over 4,000 votes at the next elections.
(No,) stopping the boat:The New Conservative Group’s manifesto is not good news for Sunak. It shows how he is struggling to fulfill his promise to “stop” the boats, which was one of five pledges that he made to himself six months ago.
5 alive The Times gives a damning evaluation of Sunak’s progress in achieving his five pledges. The Times scores Sunak from 1 out 5 for reducing national debt, to a not so impressive 3 out 5 for the prospects of growing the economy.
ICYMI If he had not received enough helpful advice by the weekend, it was reported that Liz Truss, former PM of Australia will be launching her new “Growth Commission”, later this month. The group, led by economist Douglas McWilliams will examine the causes of slow growth and analyze the impact of government policy on GDP.
POLLTASTICMore bad results for Sunak from a series of polls released overnight. Two-thirds of respondents to a BMG survey for the i blamed the government for high prices. The paper reported the results. The same poll found that 45 percent of respondents now believe Britain should join the EU. This compares to 40 percent who would like to remain out and 14 percent are unsure.
Polls, Part 2:A separate poll conducted by Ipsos on behalf of the Health Foundation found that two-thirds (67%) of voters believed the NHS would abandon the principle of providing free care at the time of delivery. That’s what the Guardian splashed.
On this note: Aneira, the retired nurse and first baby born in the NHS, gave an interview to The Mirror to mark its 75th anniversary. She accused the government of taking health care back to “dark times.”
Polls, Part 3:The Mail reports on a poll that shows only one out of four voters support the campaign to delay 2030’s ban on petrol and Diesel car sales. Kemi Badenoch, the UK’s Trade Secretary, is said to be concerned that the deadline may affect car manufacturing in the U.K.
Read this: Badenoch is increasing pressure on the EU in order to protect electric vehicle manufacturers from being affected by new Brexit trade regulations in 2024. My POLITICO colleagues Graham Lanktree, and Stefan Boscia have reported.
The economy must be in bad shape:Nick Timothy declared that capitalism isn’t working.
We’re here to help:Altruism is still alive and well. The Times has an article on the Patriotic Millionaires – a group of Richie Riches that calls for the wealthy pay more taxes.
ANOTHER TORY HEADACHE: There is a lot of unhappiness on the Tory back benches — and even some on the front benches — about the anti-BDS bill (Boycott, Divestment, Sanctions), Playbook’s Eleni Courea hears before its second reading tonight. Around 10 Tory members met with Chief Whip Simon Hart to express their concerns last week (but the real number of rebels “is much more than that,” said one MP).
The purpose of the bill…was that it would ban local councils from a boycotting Israel – fulfilling a manifesto promise. This was not a surprise to anyone, but it was a hot political topic and difficult to codify. Eleni has spoken with multiple Tory MPs, who are concerned about the bill’s single-out of Israel, its potential to stifle criticism or action against other countries, including China, as well as the threat it poses to freedom of expression. Alicia Kearns, chair of the Foreign Affairs Committee, is expected to speak during the debate.
Trouble on both sides:The FT says that John McDonnell, the Shadow Chancellor, will vote against the Bill. The paper also reports that Labour MPs were ordered to abstain.
On a different note: Former Chancellor Sajid Javid wrote an op-ed for the Telegraph in support of the bill. The bill is being led by Michael Gove, Leveling Up Secretary and local government official. Javid says that the legislation will prevent local councils from “‘freelancing,’ in foreign policies.”
HAIL THE CHIEFSomething for the PM to cheer up: U.S. president Joe Biden is stopping by London next week on his way to Vilnius, where the NATO summit will take place. The White House announced this. In a visit to “strengthen our close relationship with our nations”, Press Secretary Karinejean-Pierre stated in a press release. He will call on Rishi Sunak as well as King Charles. Hugo Gyre of the i got the scoop two weeks ago.
WINDSOR AGREEEMENT Buckingham Palace confirmed Biden’s meeting with the king on the evening of 10 July at Windsor Castle. The PM will be eager to see the president after a warm relationship that has developed in recent months.
You are very welcome:A number A spokesperson for 10 said last night that the prime minister is looking forward to welcoming U.S. president Biden to the U.K. in the latter part of this month. This shows the strong relationship between U.K. & U.S. It builds on a series bilateral visits & meetings earlier this year.
CLEVERLY IS IN EUROPE: Speaking of NATO, Foreign Minister James Cleverly will be in Brussels today where he’ll make his first speech before the EU Parliament and co-chair with European Commission Vice President Maros SEFCIOC the 11th Joint Committee Meeting on the Withdrawal Agreement. Cleverly will outline the U.K. priorities for cooperation on trade and Ukraine before meeting European Parliament president Roberta Metsola, and NATO Secretary General Jens Stoltenberg. They will discuss how to support Ukraine and how the NATO alliance can adapt to new threats, including increasing defense spending. Cleverly will emphasize the U.K.’s support for Sweden becoming a NATO member.
So mature Speaking ahead of the visit Cleverly said: “This marks a new chapter in U.K.-EU relations. We stand united in our support for Ukraine, and want to maximize the benefits of our trade agreement. We don’t need to agree on every issue. A mature relationship can handle differences.
BRIDGET’S BIG DAY It’s a mega-day for Shadow Education Secretary Bridget Phillipson. She has just finished her Sunday broadcast and is now promoting her plans to send “super teachers” to struggling schools in underprivileged communities. She also has an article in the Sun, promising to produce “the next generation” of brickies with construction apprenticeships. She will also be on James O’Brien’s LBC program at 12.30 pm. She’ll also help Labour leader Keir starmer launch his “mission” to increase opportunities later in the week. Phew.
Show a little respect.Labour today will also pledge to reestablish the teaching profession as a respected one, with more money for new recruits and a higher status, to address the lack of talent entering the profession. Phillipson, in pre-briefed remarks, said: “Only Labour can re-establish the teaching profession as one that is respected and valued for its skill as a job that delivers for our nation.”
Private pledgePhillipson’s promise to reward teachers who complete two years of teaching with a PS2,400 bonus as a way to improve retention would be funded through the ending of tax breaks for private school. Phillipson said on Times Radio that the cost would be just over PS56million and that it would come from ending tax breaks for private schools.
Teachable Moment:Phillipson has also released figures showing that state schools have spent PS8 Billion recruiting replacement teachers since 2010
Sorcerer’s Apprentice:The Sun’s story states that the number of apprenticeships completed has dropped by 40% in the last five years. Keir Starmer’s latest “mission” address will be announcing his plans for education later this week. It will focus on how to overcome barriers.
Reminder The latest NEU strikes will be coming down the track on Wednesday and Friday like a locomotive, heading straight towards parents. Jonathan Gullis, Minister of School Standards, said: “The Conservative Government wants to put students and parents first. The NEU should do the sam.
RISE UPS: Meanwhile, former Labour Education Minister David Blunkett told the House’s Tali Frasier that he would “far less tolerant” than the current students regarding the marking strike which has ruined their graduation prospects. Their university experience had already been a mess thanks to COVID.
Cover star The latest edition of House also features an interview with Gillian Keegan whose comments on the government’s much-anticipated guidance for schools regarding trans issues were picked by the Telegraph at the weekend. She and Schools Minister Nick Gibb will meet Tory MPs at 5 p.m. to discuss the plans, amid anger among the backbenches over the “limbo”, schools have been in due to delays with the guidance.
OOH la Lammy: Shadow Foreign Secretary David Lammy will be in Paris today for talks with French Minister of Foreign Affairs Catherine Colonna on the Quai D’Orsay. He will then meet with Transport Minister Clement Beaune. They will discuss Labour’s plans to “rebuild U.K. – France ties, as well as the proposed U.K. – EU security pact.”
Talks in the tank:Lammy is also visiting the think tank Institut Montaigne while he is in Paris. While in Paris, he will present proposals for a new agreement on safe return and family reunion and pledge to crackdown on smugglers gangs. According to a press release issued before the trip, Lammy plans to say that he wants “to make Brexit work for the British public by fixing the gaps in the Tories botched Brexit deal during the scheduled Trade and Cooperation Agreement Review 2025.”
POUNDSHOP BLAIRITESKeir’s purge of the Left and last week’s disciplinary actions against Compass chief Neil Lawson because he tweeted about electoral pacts show that the Labour leadership wants to replace lefties by “pound-shop Blairites,” Poppy Wood reports for the i.
They came for me next:On a similar theme, John McDonnell, the former Shadow Chancellor told the FT that the leadership was looking for an excuse for him to be suspended. Gotta love “Starmer’s ally’s” response to the notion that the trigger could be tonight’s Israel boycott bill. “That’s not something anyone wants to fight.”
ASIAN ASLANSThe Twitter spat between superhead Katharine Burbalsingh, and Labour frontbencher Jess Phillips makes Playbook’s brain hurt. Luckily, the Guardian’s Rowena Mason had the stamina it took to write about it.
MIDDLE AGE MAYHEM: Women aged 45-65 could be the key to Labour and Lib Dems’ fortunes in the general election, according to the Times. For those who enjoy archetypes, this report adds the words “Surrey Shufflers,” a “Take a Breaker,” “WI” and “National Trusters.”
SEEING YOU AGAIN IN COURT: The second day of the Cabinet Office vs. COVID inquiry High Court Case over the release of Boris Johnson’s unredacted WhatsApps During the Pandemic begins in court 3 at 10.30 am.
SHADES of GRAY: The results of the government’s investigation into Partygate Inquisitor Sue Gray’s contacts with Labour, will be presented to parliament today in the form a WMS. Labour’s response is essentially: “whatever”, the Mail reports.
BROKEN BRITAIN The BMA Annual Conference starts today in Liverpool. According to the Mirror, doctors are threatening a strike until the next general election unless an improved pay deal is reached. The union’s senior doctor, Phil Banfield will call for urgent negotiations, claiming that there is a lack of trust between doctors and the government.
Pay Up:The Times splashes a hint by Health Secretary Steve Barclay, that more money could be found if also the union moved away from its 35 percent demand. The Times reported that Barclay is in favor of adopting the recommendations from the independent Review Body on Doctors’ and Dentists’ Remuneration. This body is expected to recommend a 6 percent increase.
The robot is now watching you: Meanwhile, Barclay also ordered NHS trusts that they use the new funding (somewhat mysteriously obtained) for extra staff in order to recruit more doctors, nurses, and not bureaucrats.
NO TRUTH: According to a report published by the Times, half of women who witnessed or experienced a crime within the last year did not report the incident because they didn’t believe that the police would take their claims seriously.
THE KID IS OK:Young adults living in areas of high anti-social behaviour in England will be able to access more sports, arts, and other opportunities this summer thanks to funding from the Million Hours Fund.
PHONES:Former Tory Leader Iain Duncan Smith warned that the merger between Vodafone & Three was “dangerous,” as it could give a Chinese-based company a prominent position in the U.K. mobile network. Duncan Smith told The Independent: “This dangerous deal is another example of the Communist Party’s attempt to create a Western dependence on China.”
DON’T BANK IT:The Telegraph reports on the Treasury telling banks they must protect freedom speech following a growing outcry over customers with controversial views being blacklisted. Chancellor Jeremy Hunt, it is believed, is “deeply worried” about lenders closing down accounts because they disagreed with the opinions of customers. He has asked Andrew Griffith, City Minister, to investigate.
FUELING the FLAMES:The Government plans to crackdown against service station profiteering, by telling motorists through a comparison site where they can purchase the cheapest gasoline. The Telegraph has an article.
FACING MUSIC:Evidence Week begins in parliament. The event, which was created in 2018 to respond to the public’s growing interest in policy evidence and will be livestreamed starting at 5 pm, allows constituents to ask their MPs questions about policy decisions.
SW1 ACTIVITIES:Former Minister of Finance Sajid Javid talks about his time at the Institute for Government with Director Hannah White starting at 9.45 am.
HOUSE of COMMONSSits at 2.30 pm with Home Office Questions… and then, the main business of the day is the second reading of Economic Activity of Public Bodies Bill (Overseas Matters). Labour’s Ruth Cadbury leads the adjournment discussion on crime and antisocial behavior in West London.
WESTMINSTER HAL: Debate from 4.30 pm an e-petition regarding the Approved mileage Allowance Payment Rate (led by Tory MEP Elliot Colburn).
On the committee corridor:Directors of Public Prosecutions Max Hill give evidence to the Justice Committee at 2.30 p.m…. NHS England’s Chief Executive Amanda Pritchard and DHSC’s Permanent Secretary Chris Wormald speak to the Public Accounts Committee regarding access to emergency and urgent care at 4 p.m…. and Electoral Commission representatives are questioned about electoral registration by the Leveling
HOUSE of LORDS: Sits at 2.30 pm with oral questions about the Drax biomass power plant, the U.K. production of nuclear subs under the AUKUS Agreement and recommendations on cybersecurity… and then main business is the Illegal Immigration Bill on the second day.
PILE ON PYLONSEnvironment secretary Therese Coffey has launched a campaign against the section of a pylon line that will cross her Suffolk Coastal Constituency. Kemi Badenoch who represents Saffron Walden, Essex, also called for a reconsideration. The Telegraph published a piece on the subject. It follows the Sunday Telegraph splash that said hundreds of miles of pylons would be accelerated so the U.K. could meet its net-zero goals.
YET A NEW MAYOR:Tory MEP Ben Bradley announced that he was running to become the first mayor of East Midlands. He called for the region to have the power to reduce taxes. Bradley pledged in a Telegraph article that he would not introduce ULEZ policies, as seen in London and other cities.
ORKNEY GOES NORDIC: Orkney Council will discuss “alternative governance forms” with their Nordic neighbor. James Stockan, the authority leader, believes Orkney is not treated fairly in terms of funding and policy support. Orkney could do better under the Norwegians. STV News has this story.
VICTORIA REMEMBERS:Ukrainian war crimes researcher and writer Victoria Amelina, 37, died after being injured in Kramatorsk by a Russian missile. Journalist Olga Tokariuk stated that Amelina left “so many unwritten books, stories untold and days unlived.”
TRADE AWAYTrade minister Nigel Huddleston is on a three-day trip to Kolkata, India, and Dhaka Bangladesh to announce initiatives to help U.K. companies sell to both countries.
RIOTS IN FRANCE SHOW SIGNALS OF DEESCALATION After six nights of looting, violence and clashes the French authorities seem to be deescalating the riots which broke out in France after a policeman killed Nahel a 17-year old of North African descent during a traffic check in Paris last Thursday.
Over this weekend: On Sunday night, tens of thousands more police were sent on patrol to try to prevent further rioting. On Saturday, President Emmanuel Macron rescheduled a trip to Germany in order to deal with the crisis at home. John Lichfield writes in a commentary for POLITICO that the riots have created a “spiral” of suspicion, misunderstandings, rejections and fear.
**A Message from Google:Since the year 2015, Google has offered free digital skills training in more than 500 locations across the UK. From Manchester to Port Talbot to Sunderland, Bristol to Bristol, Google ensures that small businesses and individuals are equipped with the skills needed to grow. Find out more about our free training in digital skills here. **
Culture Minister Lucy Frazer broadcast round :Sky News (7:30 a.m.),… LBC (7:30 a.m.),… GMB (8.30 am.).
Shadow Schools minister Stephen Morgan broadcast round :GB News (7.20 a.m.), Times Radio (7.45 a.m.), Sky News (8.05 a.m.), LBC News (8.40 a.m.).
Also, on GB News Breakfast :Former Tory advisor Claire Pearsall (6.30 a.m.; 7.30 a.m.; and 8.30 a.m.).
Also heard on Times Radio: Former Victims’ Commission Vera Baird (7.35 am)… Ineos Chairman and Founder Jim Ratcliffe (8:00 am)… Susan Hall a shortlisted Tory candidate for London mayoral election (8.35 am).
Also on Sky News Breakfast : ASLEF general secretary Mick Whelan (7.20 am)… Rwandan leader of opposition Victoire Umuhoza (7.35)… BMA junior doctors committee member Arjun Sing 8.30 am
Also, on Nick Ferrari’s Breakfast: Former Met Police Commander Roy Ramm (7.05 a.m.)… Former Met Police Superintendent Nusrit mehtab (8.35 am.).
TalkTV breakfast:Former Tory health secretary Stephen Dorrell (7.05 am)… crossbench peer Norman Warner 8.05.
Politics Live (BBC Two, 9.45 a.m. ): Tory MP Bim O’Grady… Labour peer Frances O’Grady… Alex Phillips of Reform U.K…. Observer’s columnist Sonia Sodha.
James O’Brien Shadow Education Secretary (LBC). Bridget Phillipson Phone-in (12.30 to 1.00 pm).
POLITICO UK Brexit cliff edge has electric carmakers spooked, as talks falter.
Daily Express Doctors raise the specter of NHS strikes up to 2025.
Daily Mail Stop the “damaging” 2030 petrol vehicle ban
Daily Mirror “Super Teacher” hit squads for Schools
Daily Star China’s lunar nukes
Financial Times Bond fund titan Pimco prepares to “harder land” in the global economy
i : Voters blame Sunak for “poor” handling inflation.
Metro : Just Not Cricket!
The Daily Telegraph Banks should respect the right to free speech of their customers
The Guardian Fears that NHS will have to charge for services are growing.
The Independent – Shameful
The Sun : Out of… order.
The TimesDoctors will get a pay promise if they end their strike.
WESTMINSTER METEOROLOGY: Light Rain with a Moderate Blow. Highs of 19C.
IN MEMORY: Former civil service head Bob Kerslake died of cancer at the age of 68, according to his sister Ros Kerslake Labour leader Keir starmer said Kerslake is a “talented professional, and good man”. His daughter Eleanorsaid Kerslake has had many jobs, but the most important thing to him was that he was a fantastic husband, father, brother, son, and granddad.
NEW GIG Donjeta Miftari is now a political advisor to Labour’s National Coordinator Shabana Mahamood. She was previously the chief communications adviser for Kosovo’s president Vjosa Omsmani.
Kate McCann Congratulations to Kate McCann, who will be the political editor of Times Radio from September. She was previously the political editor of TalkTV.
STRAWBERRIES & CREAM PLEASE! Wimbledon coverage starts on BBC Two at 10.30 am, bringing Politics Live forward.
LISTEN: Kirsty Warsk discusses NHS at 75, with guests including The Spectator’s Isabel Hardman GP Phil Whitaker on Radio 4’s “Start the Week” at 9 a.m.
ROLL THE BARREL : Journalist Nadine White’s first film about the Windrush Generation, titled “Barrel Children,” plays now in select Picturehouse cinemas. Dates are listed here.
NOAH’S CULTURE FX:Comedian Matt Forde interviewing fellow comic Joe Lycett at the Duchess Theatre, 7.30 pm. Tickets are available here.
READ NOW: The New Statesman interviews Facebook Whistleblower Frances Haugen who expresses concerns about the impact Big Tech will have on the U.S. elections in 2024.
BIRTHDAYS – Former Ealing North M.P. Stephen Pound… Scottish Labour MSP Katy Clark… Maitland Jay Turner… WikiLeaks founder Julian Assange.
Playbook wouldn’t have been possible without my editors Jack Lahart, Zoya Sheftalovich and Noah Keate. Producer Dato Parulava and reporter Noah Keate also contributed.
London Playbook Global Insider
Strategic acquisition helps Tonix build its commercial capabilities and infrastructure ahead of potential launch of TNX 102 SL to manage Fibromyalgia
Tonix’s current intranasal clinical development program of TNX-1900, for migraine prevention, is complemented by the acquisition of Zembrace (r) SymTouch (r) and Tosymra (r) (sumatriptan spray).
CHATHAM, N.J., JULY 03, 2023 — Tonix Pharmaceuticals Holding Corp., a biopharmaceutical firm, and its wholly-owned subsidiary Tonix Medicines, Inc., (Tonix Medicines), announced today that they have completed the acquisition of the two currently-marketed products by Upsher-Smith Laboratories, LLC. Zembrace SymTouch (sumatriptan injectable) 3 mg, and Tosymra (sumatriptan) (ups) (Ups) (Ups) (Ups) (Ups) (Ups) (Ups) (Ups) (Ups As previously announced, the combined product sales for these products were approximately $23 millions in 2022.
Seth Lederman M.D. is the Chief Executive Officer at Tonix Pharmaceuticals. He said that the acquisition of these products represents a significant step in Tonix’s evolution into a fully-integrated biopharmaceutical firm and builds on Tonix’s expertise in central nervous system disorders. “In addition to the growth potential that these two products represent over time the acquisition helps Tonix build its commercial capabilities ahead of the possible launch of our TNX 102 SL product for the treatment fibromyalgia and aligns strongly Tonix’s TNX-1900 product candidate (intranasal-potentiated oxytocin), which is in clinical development.
“Migraine and breakthrough headaches are still a significant burden. We believe that both Zembrace SymTouch, and Tosymra, can be used to meet the unmet needs of those patients who use oral acute migraine medications currently, or have recently developed, especially for rapid-onset treatment,” stated James Hunter, Executive vice president of commercial operations at Tonix Pharmaceuticals, and President of Tonix Medicines.
It is the only sumatriptan-autoinjector brand actively promoted in the United States. Other sumatriptan-autoinjectors on the market include Imitrex (r) and generics of Imitrex (r). It is a low-dose product that has shown migraine pain relief as early as 10 minutes (17% of patients vs. only 5% of placebo patients). 2 Zembrace SymTouch has also demonstrated migraine freedom for 46% (vs. 27% for the placebo group) at 2 hour in a double-blind, single-attack study (N=230). 3 Zembrace SymTouch has patent protection until 2036. Tosymra uses Intravail(r), a permeation enhancer, and is pharmacokinetically equal to 4 mg of subcutaneous sumatriptan.
About Migraine
Nearly 40,000,000 Americans suffer from migraine 7. It is the second leading cause for disability in the United States.
References:
IQVIA 2022 estimates Zembrace and Tosymra retail sales at $19.6M and $3.5M respectively.
Mathew NT, et al. Subcutaneous sumatriptan is effective and safe in doses ranging from 1 to 10 mg. US Sumatriptan Research Group. Arch Neurol. 1992;49(12):1271-1276.
Landy, S. et al. Efficacy of DFN-11 (3 mg sumatriptan) in adults with episodic headache: a multicenter, double-blind placebo-controlled, randomized study. J Headache Pain. 19, 69 (2018).
Brand-Schieber E, Munjal S, Kumar R, et al. Human factors validation of 3 mg sumatriptan injector for migraine patients. Med Devices (Auckl). 2016;9:131-137.
Tosymra [package leaflet]. Maple Grove, MN, Upsher-Smith Laboratories, LLC, Feb 2021.
Wendt J, et al. A randomized, controlled, double-blind trial evaluating the efficacy and safety of a subcutaneous dose of sumatriptan of 4 mg for the treatment acute migraine attacks among adults. Clinical Therapeutics. 2006;28(4):517-526.
GBD 2016 Headache Collaborators. Global, regional, national, and local burden of migraine and tension type headache, 1990-2016 : a systematic study for the Global Burden of Disease Study 2016 Lancet Neurol 2018;17(11):954-976.
Headache Classification Committee (IHS) The International classification of headache disorders in its 3rd edition. Cephalalgia. 2018;38(1):1-211.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical firm that focuses on commercializing, developing and discovering therapeutics to treat, prevent and alleviate human disease. Tonix sells Zembrace(r), SymTouch (r) (sumatriptan injectable) 3 mg, and Tosymra (r) (sumatriptan spray) 10mg. Both are indicated for acute migraines with or without aura. Tonix’s product portfolio consists of candidates for the central nervous system, rare diseases, immunology and infections. Tonix’s CNS portfolio includes small molecules and biologics for treating pain, neurologic and psychiatric conditions, as well as addiction. Tonix’s leading CNS candidate (TNX-102 SL, cyclobenzaprine HCl Sublingual Tablet) is in Phase 3 development for the treatment of fibromyalgia. Topline data are expected in the first quarter 2024. TNX 102 SL is being developed for the treatment of Long COVID (a chronic post-acute COVID-19). The Phase 2 study enrollment is complete, and topline findings are expected to be available in the third quarter 2023. TNX-601 (tianeptine extended-release tablets), an oral once-daily formulation that is being developed to treat major depressive disorder, is also enrolling. Topline results are expected in the first half of 2024. TNX-4300 is a small molecule orally administered therapeutic that is in preclinical testing to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1900, intranasal-potentiated oxytocin, in development for chronic headaches, is currently enrolling. Topline data are expected in the fourthquarter of 2023. TNX-1300, a biologic that treats cocaine intoxication, has been designated as a Breakthrough Therapy by the FDA. A Phase 2 study for TNX-1300 should begin in the third quarter 2023. Tonix’s portfolio of rare disease development includes TNX-2900, an intranasal potentiated oxytocin for the treatment Prader-Willi Syndrome. TNX-2900 was granted Orphan Drug status by the FDA. Tonix’s Immunology Development Portfolio includes biologics that address organ transplantation rejection, autoimmunity, and cancer. TNX-1500 is a humanized, monoclonal, antibody targeting CD40L (CD154), which is being developed to prevent allograft reject and treat autoimmune diseases. A Phase 1 study for TNX-1500 should begin in the third quarter 2023. Tonix’s pipeline of infectious diseases includes TNX-801 – a vaccine being developed to prevent smallpox or mpox. TNX-801 can also be used as a platform for recombinant pox or live virus vaccines to treat other infectious diseases. The portfolio of infectious disease development also includes TNX-3900, TNX-4000 and classes of broad spectrum small molecule antivirals.
* Tonix’s product development candidates are investigational drugs or biologics that have not been approved by the FDA for any indication.
Tonix Medicines is the registered trademark owner of Zembrace SymTouch, Tosymra and Tosymra. Intravail, a registered trademark, is owned by Aegis Therapeutics, LLC, which is a wholly-owned subsidiary of Neurelis, Inc.
You can find this press release as well as additional information about Tonix at www.tonixpharma.com.
Forward-Looking Statements
Certain statements in this release are forward-looking, as defined by the Private Securities Litigation Reform Act of 1996. These statements can be identified by forward-looking words like “anticipate”, “believe”, “forecast”, “estimate”, “expect”, and “intend”. These forward-looking statement are based on Tonix’s current expectations, and actual results may differ materially. There are several factors that could cause the actual events to differ significantly from those stated in such forward-looking statement. These factors include but are not restricted to risks related the failure to obtain FDA approvals or clearances and non-compliance with FDA regulation; risks related the failure of our products to be successfully marketed; risks relating to the timing and the progress of clinical development for our product candidates; risks relating to our need for additional funding; uncertainties regarding patent protection and litigation, uncertainties regarding government or third party payer reimbursement; limited research efforts and dependence on third parties; and significant competition. As with any pharmaceutical product in development, there are risks associated with the development, approval by regulatory agencies, and commercialization of a new product. Tonix is not obligated to update or revise forward-looking statements. Investors are advised to read the risk factors in the Annual Report on the Form 10-K for year ending December 31, 2022 as filed with Securities and Exchange Commission (“SEC”) March 13, 2023 and periodic reports filed at or after that date. All forward-looking statements by Tonix are expressly qualified with all of these risk factors and cautionary statements. The information contained herein is only current as of the date it was published.
Investor Contact
Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 904-8182
Peter Vozzo
ICR Westwicke
[email protected]
(443) 213-0505
Media Contact
Ben Shannon
ICR Westwicke
[email protected]
(919) 360-3039
Zembrace(r) SymTouch(r) (sumatriptan Injection): IMPORTANT SAFETY INFORMATION
Zembrace SymTouch can cause serious side-effects, including heart attacks and other heart problems that may lead to death. If you experience any symptoms of a heart attacks, stop using the product and seek emergency medical attention.
Discomfort in the middle of your chest that lasts more than a few moments or comes and goes
Severe tightness, pain, or pressure in your chest, neck, jaw, or throat
You may experience pain in your arms, back or neck, jaw, or stomach
Shortness of breath without chest discomfort
Breaking out in cold sweat
nausea or vomiting
Feeling lightheaded
Zembrace should not be used by people with heart disease risk factors (high blood pressure, high cholesterol, smoking or being overweight, diabetes, a family history of heart problems, etc.) unless an examination of the heart shows that there is no problem.
Zembrace should not be used if you:
Heart problems in the past
Narrowing of blood vessels in your legs, arms or stomach (peripheral arterial disease)
Uncontrolled high blood pressure
Hemiplegic migraines or basilar headaches. Ask your provider if you are unsure if you suffer from these migraines.
Have you had a stroke or TIA?
severe liver problems
Taken any of the following medications in the past 24 hours: ergotamines (dihydroergotamine), eletriptan.
If you are taking monoamine oxidase-A (MAO-A) inhibitors, or if it has been less than 2 weeks since you stopped taking MAO-A inhibiters. If you are unsure, ask your doctor for a list.
Zembrace is not recommended for people who have an allergy to sumatriptan, or any of its components.
Tell your provider all your medical conditions, medications and vitamins and supplements you take.
Zembrace may cause dizziness or weakness. If you feel drowsy, do not drive, operate machinery, or perform any other activity that requires alertness.
Zembrace can cause serious side effects, including:
Changes in color or sensation of your fingers and toes
Weight loss, nausea, vomiting, constipation, diarrhea, or bloody diarrhea
If you experience any of the following symptoms, please consult your doctor.
Increased blood pressure, including a sudden and severe increase even if there is no history of high pressure
Medication overuse headaches are caused by taking migraine medication for more than 10 days per month. If your headaches get worse, call your provider.
Serotonin Syndrome is a rare, but serious, problem that can occur in people who use Zembrace. This is especially true when combined with antidepressant drugs called SSRIs and SNRIs. Call your doctor immediately if you experience mental changes, such as seeing things not there (hallucinations), agitation or coma, a fast heartbeat, changes in blood pressure or high body temperature.
Hives (itchy bumps); swelling in your mouth, throat, or tongue
Even people who have never experienced seizures can experience seizures
The most commonly reported side effects of Zembrace are: Pain and redness around the injection site, tingling in your fingers or toes, dizziness, a warm, hot or burning sensation on your face (flushing), discomfort or stiffness in the neck, feeling weak, drowsy or tired.
Inform your provider if any side effects bother you or do not go away. These are not the only possible side effects that can occur with Zembrace. Ask your provider for more information.
The information below is important but not exhaustive. Talk to your doctor and read the Patient Information & Instructions for use. You can also call 1-888 650-3789 or visit www.upshersmith.com.
Reporting adverse effects of prescription medications to the FDA is encouraged. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INDICATIONS AND USAGE
Zembrace, a prescription medication, is used to treat migraine headaches in adults with or without aura.
Zembrace does not prevent migraines. It is unknown if Zembrace is safe and effective for children under the age of 18.
Tosymra(r) (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION
Tosymra may cause serious side effects including heart attacks and other heart problems that can lead to death. If you experience any signs of a heart attack, stop taking Tosymra immediately and seek emergency medical attention.
Discomfort in the middle of your chest that lasts more than a few moments or comes and goes
Severe tightness, pain, or pressure in your chest, neck, jaw, or throat
You may experience pain in your arms, neck, jaw or stomach.
Shortness of breath without chest discomfort
Breaking out in cold sweat
nausea or vomiting
Feeling lightheaded
Tosymra should not be used by people with heart disease risk factors (high blood pressure, high cholesterol, smoking, obesity, diabetes, family history, etc.) unless an exam of the heart shows that there is no problem.
Use Tosymra only if you do not have:
Heart problems in the past
Narrowing of blood vessels in your legs, arms or stomach (peripheral arterial disease)
Uncontrolled high blood pressure
severe liver problems
Hemiplegic migraines or basilar headaches. Ask your healthcare provider if you are unsure if you suffer from these migraines.
Have you had a stroke or TIA?
If you have taken any of these medicines within the last 24 hours, please let your provider know. If you are unsure if your medication is listed, ask your provider.
If you are taking monoamine oxidase-A (MAO-A) inhibitors, or if it has been less than 2 weeks since you stopped taking MAO-A inhibiters. If you are unsure, ask your doctor for a list.
Tosymra or any of its ingredients can cause an allergic reaction to sumatriptan
Tell your provider all your medical conditions, medications and vitamins and supplements you take.
Tosymra can cause dizziness, weakness, or drowsiness. If you feel this way, avoid driving a car or using machinery.
Tosymra can cause serious side effects, including:
Changes in color or sensation of your fingers and toes
Weight loss, nausea, vomiting, constipation, diarrhea, or bloody diarrhea
If you experience pain or cramping in your legs and hips, you may also experience a feeling of heaviness in the muscles. You may also experience burning or aching in your toes or feet while at rest, or numbness.
Increased blood pressure, including a sudden and severe increase, even if there is no history of high pressure
Overuse headaches are caused by taking migraine medication for more than 10 days per month. If your headaches get worse, call your provider.
Serotonin Syndrome is a rare, but serious, problem that can occur in people who use Tosymra. This occurs more often when combined with antidepressant drugs called SSRIs and SNRIs. Contact your doctor immediately if you experience any of the following: mental changes, such as seeing things not there (hallucinations), agitation or coma.
Hives (itchy bumps); swelling in your mouth, throat, or tongue
Even people who have never experienced seizures can experience seizures
Tosymra’s most common side effects include: tingling or dizziness; feeling hot or warm; feeling of heaviness and pressure. Other symptoms include flushing, tightness, numbness.
Inform your provider if any side effects bother you or do not go away. Tosymra can cause other side effects. Ask your provider for more information.
Tosymra is not covered in this list. Talk to your doctor and read the Patient Information & Instructions for use. You can also call 1-888-650-378 or visit www.upshersmith.com.
Reporting side effects of prescription medications to the FDA is encouraged. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INDICATIONS AND USAGE
Tosymra, a prescription medication, is used to treat adults with acute migraine headaches that may or may not have an aura.
Tosymra cannot be used to treat other types headaches, such as hemiplegic migraines, basilar migraines, or cluster headaches.
Tosymra does not prevent migraines. Tosymra may be safe and effective for children under the age of 18.
CHICAGO(CBS) — The NASCAR racing action is just hours away. But if you’re anywhere near downtown you saw the traffic snarl up as the roads were closed for the race.
CBS 2’s Marybel González reported that it was already a problem for some people Friday evening trying to get into and out of downtown, with roadblocks being set up on busy roads.
This weekend will be a whirlwind of activity, as not only the big race is taking place but also the July 4th celebrations.
There was excitement in the air as the Chicago NASCAR Street Race was about to begin.
Cody Jones, NASCAR engineer, said, “Everyone is driving past where we were parked – windows down and pumping their fists, cheering us on.”
The organizers laid out the red carpet to the adventurous racers.
“I expected it would be cool, but didn’t expect it be as big as it is – you know, the whole town shut down just for us,” said NASCAR driver Corey LaJoie.
But it wasn’t all glitz and glamour. Traffic jams have already been caused by the roadblocks and closings.
Some people struggled to enter the city, while others struggled to leave it.
“We’ve been waiting for a half-hour for a bus because all the routes have been rerouted and there are no other options – we’re stuck,” said a woman at the corner Washington and State streets. “That’s a problem.”
The race was not the only thing that caused the traffic to increase on Friday evening. AAA estimates that nearly 3 million people will be driving for the holiday weekend, a record.
There was a lot of traffic and also heavy security.
On Friday evening, police officers were already standing by at the downtown intersections. CPD also cancelled its days off to prepare for the busy holiday weekend.
Chicago Transit Authority has also put all hands on deck for this busy weekend. The Chicago Transit Authority said that there will be several bus reroutes within the downtown area. You can find a breakdown here.
The CTA recommends that you travel to the race using the ‘L’ train.
Migraine sufferers have experienced severe headaches.
A migraine attack can be painful, disorienting, and even debilitating.
Fox News Digital spoke with Lauren R. Natbony M.D. during National Migraine and Headache Awareness Month to dispel some common myths and misunderstandings about this condition.
MIGRAINE NATAL SPRAY FROM PFIZER GETS FDA APPROVAL FOR ESTIMATED SUMMER LAUNCH
Natbony, the founder and medical director at Integrative Headache Medical of New York, explained how migraines are different from headaches. They are “a debilitating neurological disorder characterized by recurrent attacks of severe head pain.”
Mayo Clinic reports that migraines can also be accompanied by sensitivity to sound and light, and cause nausea and vomiting.
A migraine headache is characterized by recurrent episodes that cause severe head pain.
According to the 2020 Census, 31 million adults in America suffer from migraines.
The Migraine Research Foundation reports that more than 90% of migraine sufferers are unable to function normally or work during an attack.
More than 37 million Americans suffer from migraine pain.
Paige Daufenbach, a college student and migraine sufferer, told Fox News Digital how a “bad attack” causes her nausea, “drilling head pain”, auras, and sensitivity to sound and light.
MIGRAINE VS. HEADACHE – HOW TO TELL THE DISTINCTION AND WHEN TO SEEK HELP
“In the worst case, I can’t get out of bed. I need to lie down without lights on,” she said.
Natbony explains that not all migraine attacks are alike.
Migraine symptoms can include nausea, sensitivity to sound and light. One doctor said that each patient’s migraine experience is “unique” and therefore, treatment can vary. (iStock)
She said that “each of my migraine patients is unique, and each one requires a unique treatment plan.”
The treatment for migraine is not one size fits all.
Natbony suggests that a “comprehensive strategy” for migraine prevention is “vital”. This could include lifestyle changes, preventative treatments and rescue steps.
She said that it may take some time to find the best combination of treatments. “I tell my patient that we should keep trying different strategies such as medication, lifestyle modifications and alternative therapies until we find the best one.”
“In the worst case, I can’t get out of bed. I need to lie down without lights on.”
She said that lifestyle modifications include getting regular rest, drinking at least 64 ounces per day of water, eating a meal or snack rich in protein every three to four hour, and doing cardio exercise for 30 to 45 minutes at least four days a week.
STUDY: REM SLEEP IS LOWER IN MIGRAINE SUFFENDERS
The neurologist stressed that preventative treatment is necessary when headaches are experienced six days or more per month, or if they are “debilitating”.
She explained that the goal of preventative treatment is to reduce the frequency and severity migraine attacks.
Acupuncture can be used to treat migraines.
“Preventative treatments include vitamin supplements and prescription medications as well as medical devices, acupuncture, and biofeedback, among others,” Natbony said.
During an attack, “rescue” treatments are used to relieve pain and symptoms.
Natbony explained that most of these acute medications work best when taken early during an attack due to central sensitization, a process which causes the nervous system become hypersensitive to painful stimuli.
First MIGRAine drug to both block, tackle headaches’shifts paradigm’ of treatment
She explained that triptans, gepants, and over-the counter pain relievers can be taken early to stop the migraine process. This is before central sensitization has fully developed.
Natbony recommends nasal sprays as an alternative to relieve migraine symptoms. These nasal sprays deliver the medication directly into the upper nasal cavity, avoiding the GI system — a route ideal for central nervous systems drugs, according a review by the U.S. Neurology in 2020.
(iStock).
“This spray also provides fast pain relief, no matter when it is used to treat a migraine,” said she.
“It’s effective both at the beginning and after central sensitization is established,” she added.
So, “with this medicine, patients do not need to worry about missed treatment windows.”
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The Journal of Head and Face Pain published a survey in 2017 that revealed 96% of respondents who took oral acute prescription medications for migraines were not satisfied with their treatment.
Natbony explained that oral medications take longer to reach therapeutic blood levels due to the breakdown of the medication in the stomach and the absorption into the intestines.
(iStock).
She said that nasal sprays are also useful for people who experience nausea and vomiting during migraine attacks. They bypass the digestive system.
Natbony said that it’s important to discuss side effects with your doctor before you try nasal treatments.
Migraine sufferers may want to consider creating a “migraine-toolbox” that includes multiple tools and techniques for tackling a migraine as soon as it begins.
Natbony says that an ideal toolbox should include preventative treatments, noninvasive medical devices, and non-pharmaceutical treatment options such as supplements, biotherapies, acupuncture, and dietary supplements.
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You can also use over-the-counter products like ice and heating packs, and essential oils.
Natbony explained that a migraine toolbox contains everything a patient might need in the event of an attack.
(iStock).
“It’s important to have treatment options that are effective because a headache can ruin your day in an instant,” she said.
Daufenbach, a migraine sufferer, revealed that she has a number of oral medications in her migraine toolbox. However, she uses her “rescue treatment” nasal spray in severe cases.
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She said, “My neurologist suggested I try the Trudhesa nasal spray because of its flexibility and its ability to provide me with fast pain relief within 15 minutes.”
She said that when she feels a migraine coming on, her left arm becomes numb and I get auras. “I know when my pills won’t give me the relief that I need. I can count [on the spray] if I have an important exam or plans that I must not miss.”
According to the American Migraine Foundation, more than 37 millions Americans suffer from migraine pain.
Editor’s note: Get inspired with a weekly roundup of simple tips for living well. Sign up for CNN Life, But Better to receive information and tools that will improve your well-being.
A new study suggests that opioid medications may not be effective in treating low back pain, despite being one of the most commonly prescribed treatments.
It is not uncommon to experience pain in the lower back and neck. According to a study of data from the Global Burden of Disease Study, neck pain is the fourth most common cause of disability in the world.
According to the North American Spine Society, chronic low back pain is defined by symptoms lasting more than 12 week.
The clinical guidelines of the society state that physicians should limit opioid use to a short period when treating this type of pain. The use of opioids for pain relief is only recommended when other pharmacological treatment has failed or if the patient cannot take them due to personal reasons.
In a press release, Christine Lin, professor at the Institute for Musculoskeletal Health of the University of Sydney, Australia, said that despite these guidelines, “there is no evidence of their effectiveness in reducing pain,” opioid pain relievers were still prescribed for people suffering from lower back and neck discomfort in many countries. Lin is the senior author of a study published in The Lancet on Wednesday.
A small group of 310 patients was studied by the scientists due to the lack of research. Patients in Sydney sought treatment for neck or lower-back pain at primary care clinics and hospitals between February 2016 to March 2022. Participants were averagely 44 years old at the start of the study and had suffered from neck or lower back pain for 12 weeks.
The participants were randomly divided into two groups. One group received a combination of up to 20 micrograms per day of the opioid oxycodone. Naloxone was used as a way to prevent constipation – a common side-effect of opioids – and keep participants from knowing which group they were. The other group was told to take a pill that contained a placebo.
Both groups received care tips from the doctor, whom they were instructed to visit weekly. The doctor reassured them and advised them to avoid bed rest, stay active and, if necessary, avoid other treatments, including nonopioids.
The authors found that opioids were no more effective than placebos in treating back and neck pain. Six weeks after treatment, the average pain score in the opioid group was 2.78 and 2.25 in placebo group. This difference increased over time. The opioid group reported more ongoing pain in weeks 26 and 52 compared to the placebo group.
The authors also discovered opioids are unlikely to relieve back and neck pain but they may also cause harm, even after short-term use.
The opioid group scored lower on mental health and had more reports of nausea and dizziness than the placebo group. Lin stated in a press release that “we also know that even a short-term prescription of opioid pain relievers increases the risk of long-term opioid misuse.”
Experts and authors of the study who were not involved in the new study have theories as to why opioids didn’t prove more effective than placebo.
Experts said that it is possible that the opioid group’s back or neck pain had more underlying causes than the authors realized — factors that are known to be resistant to opioid treatment.
According to Dr. Mark D. Sullivan, and Dr. Jane C. Ballantyne who were not involved in the study, the pain treated could have been chronic, recurring, rather than the type of pain caused by acute injury. Sullivan is a Professor of Psychiatry and Behavioral Sciences, and Ballantyne, a retired Professor of Anesthesiology, Pain Medicine, and the University of Washington.
Sullivan and Ballantyne stated that participants only had to be pain-free for 1 month before they experienced their current episode. “If many of these patients had recurrent back pain, that could explain the non-response.” Low back pain is reported to change over a period of a year.”
Dr. John Finkenberg is a San Diego-based orthopedic spine surgeon who believes that certain areas of neck and back pain need to be treated separately. He was not involved in the study.
“If someone had both going on, they will, quite frankly, have a systemic issue going on. Whether it is general arthritis or rheumatoid. We have to be cautious with patients who come in with both,” said Finkenberg, also the president of the North American Spine Society.
The authors did not collect data on the care that doctors provided in follow-up visits, so they were unable to determine whether patients followed advice or if it had any impact. Only 57% of participants indicated that they took their medication as prescribed. Just over half of those participants took more than 80% their prescriptions.
The authors believe that because opioids are not beneficial but can cause harm, they shouldn’t be prescribed for acute neck or lower-back pain.
Lin stated in the news release that doctors should instead be encouraged to focus their attention on patient-centred methods, which could include advice about staying active and simple pain relievers. “The good news for people with acute neck and low back pain is that they recover naturally within six weeks.”
The authors studied nonspecific neck or back pain, which is pain that has an unknown cause. Finkenberg argued that when doctors don’t have a clue as to the cause, they shouldn’t use opioids as a first option or a quick solution.
Nonsteroidal anti-inflammatory medications, or NSAIDS, such as ibuprofen naproxen and Celecoxib, are helpful alternatives to opioids. According to a study conducted in February, a combination of an NSAID with a prescription muscle relaxing drug can reduce pain and disability in a week.
Exercises that improve range of motion can also be helpful. Stretches can be used to improve or maintain mobility.
Finkenberg advised that people with these pains “should also use their body as a barometer.” Don’t force yourself to continue an activity if your body is uncomfortable. This could cause the area to become more inflamed, causing further pain and damage.
Finkenberg advised that if your pain or weakness persists after three to four week, you should “really go to a specialist as it is difficult to detect these subtleties of why people are experiencing discomforts.” If advanced diagnostic tests are required, it is better to get them sooner.
“In the worst case, I can’t get out of bed. I need to lie down without lights on,” she said.
Natbony explains that not all migraine attacks are alike.
She said that “each of my migraine patients is unique, and each one requires a unique treatment plan.”
The treatment for migraine is not one size fits all.
Natbony suggests that a “comprehensive strategy” for migraine prevention is “vital”. This could include lifestyle changes, preventative treatments and rescue steps.
She said that it may take some time to find the best combination of treatments. “I tell my patient that we should keep trying different strategies such as medication, lifestyle modifications and alternative therapies until we find the best one.”
She said that lifestyle modifications include getting regular rest, drinking at least 64 ounces per day of water, eating a meal or snack rich in protein every three to four hour, and doing cardio exercise for 30 to 45 minutes at least four days a week.
The neurologist stressed that preventative treatment is necessary when headaches are experienced six days or more per month, or if they are “debilitating”.
She explained that the goal of preventative treatment is to reduce the frequency and severity migraine attacks.
“Preventative treatments include vitamin supplements and prescription medications as well as medical devices, acupuncture, and biofeedback, among others,” Natbony said.
Nasal sprays can be used to relieve migraine symptoms. These sprays deliver the medication directly into the upper nasal cavity, avoiding the GI system — a route ideal for central nervous systems drugs, according a review by the U.S. Neurology in 2020.
“This allows for fast pain relief, no matter when the spray was used during a headache,” she said.
“It’s effective both at the beginning and after central sensitization is established,” she added.
“With this medication, patients do not need to worry about missed treatment windows.”
The Journal of Head and Face Pain published a survey in 2017 that revealed 96% of respondents who took oral acute prescription medications for migraines were not satisfied with their treatment.
Natbony explained that oral medications take longer to reach therapeutic blood levels due to the breakdown of the medication in the stomach and the absorption into the intestines.
She said that nasal sprays are also useful for people who experience nausea and vomiting during migraine attacks. They bypass the digestive system.
Natbony said that it’s important to discuss side effects with your doctor before you try nasal treatments.
Migraine sufferers may want to consider creating a “migraine-toolbox” that includes multiple tools and techniques for tackling a migraine as soon as it begins.
Natbony says that an ideal toolbox should include preventative treatments, noninvasive medical devices, and non-pharmaceutical treatment options such as supplements, biotherapies, acupuncture, and supplements.
You can also use over-the-counter products like ice and heating packs, and essential oils.
Natbony explained that a migraine toolbox contains everything a patient might need in the event of an attack.
“It’s important to have treatment options that are effective because a headache can ruin your day in an instant,” she said.
Daufenbach, a migraine sufferer, revealed that she has a number of oral medications in her migraine toolbox. However, she uses her “rescue treatment” nasal spray in severe cases.
She said, “My neurologist suggested I try the Trudhesa nasal spray because of its flexibility and its ability to provide me with fast pain relief within 15 minutes.”
She said that when she feels a migraine coming on, her left arm becomes numb and I get auras. “That’s when I know my pills won’t give me the relief I’m looking for, and I can count [on the spray] if I have an important exam or plans that I must not miss.”
According to the American Migraine Foundation, more than 37 millions Americans suffer from migraine pain.
Greta Tucker (then 14) suffered from terrible headaches for much of 2022.
The now 15-year old from Billerica in Massachusetts tells TODAY.com that the headaches were affecting her schoolwork and sports. “It was much more intense than a typical headache. It was a constant headache. I’d get it when I went to bed and when I woke up. “Advil, Tylenol…that didn’t work.”
Mom Sue Tucker was worried and they went to the doctor. Greta was diagnosed with an arteriovenous (AVM) malformation, a jumbled of veins nestled within her brain. These congenitally misformed veins are deadly if they rupture.
Sue Tucker told TODAY.com that there was no brain bleeding. “I was a nervous wreck, because I didn’t think she would have an aneurysm any minute.”
Sue Tucker was initially unsure if she had been worrying too much over Greta’s migraines. The teenager had just started a new drug, and severe headaches or continued headaches are rare side effects. The headaches affected Greta’s entire life. She played volleyball, softball, and ice hockey. But the pain often kept her on the sidelines.
Greta: “I had difficulty sleeping.” “I had no choice but to miss out on sports and other events. It was a terrible experience to watch others play and people take my place.”
Sue Tucker took Greta Greta to a doctor.
She says, “(The pediatrician told us) that we should contact a neurologist.” “I brought her with me to (Boston Children’s Hospital), and we saw a doctor. This person ordered an MRI.”
The doctors determined that the medication caused the headaches. However, the MRI revealed an “incidental” finding: the AVM.
Sue Tucker says, “I cried quite a bit.” “We were lucky in so many ways that she got the headaches. It’s not good, obviously. But we wouldn’t have known she had an AVM.”
Sue Tucker and her spouse were worried, so they stopped Greta playing sports until she understood what an AVM was. Greta had an angiogram performed to help doctors determine where the AVM was located in the brain.
Sue Tucker explains that “you hope that it is closer to the outer, or outer brain. But hers was literally right next to her inner brain in the middle part. This was near her mobility and speech function.” “There was a very high risk that if they did anything surgically, she would not be able to talk or paralyzed,” Sue Tucker explains.
Dr. Edward Smith, Greta’s doctor, explains that an AVM occurs when blood vessel formation in the brain is incorrect in developing babies, and blood then flows through them in an abnormal way. Experts estimate that they affect one in 10,000 people. However, it could be higher, says Dr. Edward Smith.
AVMs are often not discovered by people who have them. Greta found out about her AVM through an MRI. AVMs can rupture without the person even knowing.
“They have blood flowing through them in a manner that isn’t usual and that puts wear and tears on them, similar to driving on a bad tyre,” Smith, vice-chair of the department and codirector of the Cerebrovascular Surgery and Interventions Centre at Boston Children’s Hospital tells TODAY.com. “The scary thing about AVMs, is that you can go about your normal life and nothing will happen. If they bleed, that’s when they become very, very frightening.
AVMs don’t have many symptoms that can help people detect them before they rupture.
AVMs may cause symptoms such as:
Smith emphasizes that most headaches do not indicate a neurological condition.
Smith says that between half and 80% of people have headaches at least one time a month. “People should be concerned about scary headaches.” If you or your child are in pain, then (talk to a physician).
He notes that between 12 and 25% of AVMs that bleed are fatal.
He says, “They are one of the scariest things we see in neurosurgery and medicine.” “Greta was lucky that it was discovered before it ruptured.”
This meant that doctors were able to “proactively” treat the AVM before Greta had any problems. Although doctors have several options for treating AVMs, the most common is surgery, which Smith compares to “disarming bombs.” But brain surgery is not an option for patients like Greta. She had stereotactic radiation surgery, which is “a fancy word for really really… targeted radiation.”
Smith explains that “one (radiation beam) is very low intensity. As it zaps the healthy brain in order to reach the AVM, the damage will not be as severe as if all 10 or 20, or hundreds, of beams were to converge at the same time.”
The AVMs “shrivel up” as a result of the focused radiation, so that no blood can flow through them and bleeding is eliminated. It can take two to three years for the AVM to be completely inactive.
Smith says that there is a risk of bleeding between the time you zap it and the time the skin finally shrinks.
He adds that research has shown that not much triggers them to bleed. “They bleed because of wear and tear, which is time-dependent, and not as much if you bang on your head or lift heavy weights.”
Smith wants to assure people that AVMs are not as common as they sound.
“These are extremely rare,” he says. “People shouldn’t panic if they get a headache.”
Greta was fitted with a metal mesh face mask that was placed on her head. She was then secured to a table so the radiation would be directed at the AVM. The procedure took 15 minutes and was completed.
Sue Tucker said, “She was amazing throughout the whole thing.” “She did what it took.” She never complained.
Greta was not afraid during her treatment. She did cry a little when she learned that she had AVM.
“I felt completely safe,” she says. “If there was a problem, the doctors would be right there.”
Greta is back playing sports after undergoing stereotactic radiation therapy.
“Hockey is my main passion.” She says, “I did pretty well this season.” “I’m just getting out of softball and I had a pretty successful season too.”
Greta’s family is grateful that she was diagnosed with AVM before it caused any harm.
She says, “We were lucky that it was an accidental discovery.” “I am very grateful for that.”
She encourages parents to be advocates for their children if they notice something is wrong, especially if it seems out of the ordinary.
Sue Tucker advises, “Don’t hesitate to visit the doctor.” “If it turns to be nothing, that’s awesome.”