AbbVie to Present Data From Its Migraine Portfolio at the 2021 International Headache Congress | 2021-09-08 | Press Releases

NORTH CHICAGO, Ill., Sept. 8, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that data from its migraine portfolio will be presented at the International Headache Congress 2021, held jointly this year by the International Headache Society and the European Headache Federation, from September 8-12. The company will share a total of 23 abstracts, including two oral presentations and one abstract lecture.

“We continue to conduct research that seeks to provide additional insights into the safety, efficacy and clinical utility of our approved and investigational migraine therapies,” said Michael Gold, M.D., vice president, neuroscience development, AbbVie. “The data we’re presenting are a result of AbbVie’s ongoing commitment to driving progress in the migraine community.”

Among the new data being presented are results from an open-label, multicenter extension to the pivotal Phase 3 ADVANCE trial evaluating the long-term safety and tolerability of atogepant, an investigational, orally administered calcitonin gene-related peptide receptor antagonist developed for the preventive treatment of migraine over 40 weeks. Researchers will also share data from the Phase 1, single-center, open-label, multiple-dose study assessing the potential for pharmacokinetic drug-drug interactions between atogepant and topiramate; the observational cross-sectional UNIVERSE study examining real-world effectiveness and patient satisfaction of ubrogepant for acute migraine treatment; and the POLARIS study, a retrospective claims data analysis examining the real-world treatment patterns of oral migraine preventive medication by pharmacologic class in people with migraine.

Additional presentations will focus on the efficacy of atogepant for the preventive treatment of migraine based on further analyses from the ADVANCE trial, the safety and tolerability of investigational ubrogepant as a potential acute treatment for perimenstrual migraine, and real-world evidence regarding the safety and efficacy of CGRP monoclonal antibody therapy added to BOTOX® (onabotulinumtoxinA) for migraine prevention in adult patients with chronic migraine. Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluating the use of BOTOX® for chronic migraine will also be presented.

AbbVie abstracts and presentation details for IHC 2021 are outlined below.

Abstract Title	Presentation Details All times CT
Atogepant
Long-Term Safety and Tolerability of Atogepant 60 mg Following Once Daily Dosing Over 1 Year for the Preventive Treatment of Migraine	ePoster September 11, 2021 3:42 a.m. CT
Atogepant 60 mg Once-Daily Shows Efficacy for the Preventive Treatment of Migraine: Results From a 52-Week Open-Label Extension Trial	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Atogepant Significantly Reduces Mean Monthly Migraine Days in the Phase 3 Trial (ADVANCE) for the Prevention of Migraine	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Effects of Atogepant as Evaluated by the Activity Impairment in Migraine-Diary (AIM-D) and Headache Impact Test (HIT-6) in a 12-Week, Double-blind, Randomized Phase 3 (ADVANCE) Trial for Preventive Treatment of Migraine	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Atogepant Improved Patient-Reported Migraine-Specific Quality of Life in a 12-Week Phase 3 (ADVANCE) Trial for Preventive Treatment of Migraine	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Oral Daily Atogepant for the Preventive Treatment of Migraine Increases Responder Rates for Reduction in Mean Monthly Migraine Days	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Daily Dosing of Oral Atogepant Improved Patient-Reported Measures of Quality of Life, Activity Impairment, and Headache Impact in a 52-week Trial	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Daily Atogepant Provides a Rapid Onset and Sustained Benefit in the Preventive Treatment of Migraine	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Evaluation of The Long-Term Safety and Tolerability of Oral Atogepant 60 mg Once Daily for Preventive Treatment of Migraine: A Phase 3, 40-Week, Multicenter Extension to the ADVANCE Trial	Abstract Lecture September 12, 2021 2:45-2:55 a.m. CT
Evaluation of the Pharmacokinetic Interaction and Safety of Coadministered Atogepant and Topiramate	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Ubrogepant
Preventive Oral Migraine Treatment Utilization Patterns (POLARIS STUDY): A Retrospective Claims Data Analysis	ePoster September 11, 2021 4:51 a.m. CT
COmbining UbRogepAnt and Preventives for miGrainE (COURAGE) Study Using the Migraine Buddy Application: A Novel, Entirely Remote Design for Collecting Real-World Evidence	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Ubrogepant Users’ Experience – Patients on Ubrogepant, Characteristics and Outcomes (UNIVERSE STUDY)	Oral Presentation September 11, 2021 3:20 a.m. CT
A Novel Approach to Defining Success in the Acute Treatment of Migraine: Demonstrating Therapeutic Benefit at 1 Hour Post-Dose in the Pooled ACHIEVE I and ACHIEVE II Trials	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
A Novel Approach to Defining Success in the Acute Treatment of Migraine: Pooled Results From the ACHIEVE I and ACHIEVE II Trials	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Ubrogepant Was Safe and Well Tolerated in the Acute Treatment of Perimenstrual Migraine	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Ubrogepant Treatment When Pain Is Mild Increases the Likelihood of Achieving Pain Freedom in Participants Who Treated Migraine Attacks of Mild and Moderate or Severe Pain	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
BOTOX® (onabotulinumtoxinA)
Real-World Evidence for Control of Patients With Chronic Migraine Who Received Calcitonin Gene‒Related Peptide Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Optimal Acute Treatment Is Associated With Productivity Gains in People With Migraine: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study	ePoster September 11, 2021 3:39 a.m. CT
Consecutive Headache-Free Days With OnabotulinumtoxinA Treatment in Patients With Chronic Migraine: A Pooled PREEMPT Analysis	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Real-World Evidence for the Safety and Efficacy of CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment for Migraine Prevention in Adult Patients with Chronic Migraine	ePoster September 11, 2021 4:12 a.m. CT
Impact of Prior Monthly Headache Days on Migraine-Related Quality of Life: Results From the CaMEO Study	ePoster (on-demand only) September 8, 2021 1 a.m.-1:15 p.m. CT
Characterizing Preventive Treatment Gaps in Migraine: Results From the CaMEO Study	Oral Presentation September 10, 2021 8:15 a.m. CT

About Atogepant

Atogepant is an investigational, orally administered, CGRP receptor antagonist (gepant) specifically developed for the preventive treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks, and selective CGRP receptor antagonists confer clinical benefit in migraine. Atogepant is currently under review by the U.S. FDA.

About BOTOX®

BOTOX® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Today, BOTOX® is FDA-approved for 12 therapeutic indications, including Chronic Migraine, overactive bladder, leakage of urine (incontinence) due to overactive bladder caused by a neurologic condition in adults, cervical dystonia, adult and pediatric spasticity, severe underarm sweating (axillary hyperhidrosis), and pediatric detrusor overactivity associated with a neurologic condition.

BOTOX®(onabotulinumtoxinA) Important Information in the United States

Indications

BOTOX® is a prescription medicine that is injected into muscles and used:

• To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
• To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder caused by a neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication
• To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
• To prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
• To treat increased muscle stiffness in people 2 years of age and older with spasticity
• To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
• To treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age and older

BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.

It is not known whether BOTOX® is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles.

It is not known whether BOTOX® is safe and effective for severe sweating anywhere other than your armpits.

IMPORTANT SAFETY INFORMATION

BOTOX®may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:

• Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
• Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus.

BOTOX® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive BOTOX®if you: are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Do not receive BOTOX®for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post treatment, if required, should be considered for treatment.

Patients treated for overactive bladder:

In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX® compared to 2 of the 542 treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than nondiabetics.

Adult Patients treated for overactive bladder due to neurologic disease:

In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7). Among patients not using CIC at baseline, those with MS were more likely to require CIC post injection than those with SCI.

The dose of BOTOX®is not the same as, or comparable to, another botulinum toxin product.

Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, dizziness, or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® should be discontinued.

Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing from typical doses of BOTOX®.

Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX® for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX®.

Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.

Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX®.

Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in adults receiving BOTOX® for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity. In pediatric patients treated with BOTOX® for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX® for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo.

Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in adult patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).

Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX®in the past.

Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin®in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX®include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include urinary tract infection and painful urination. In children being treated for urinary incontinence, other side effects include urinary tract infection and bacteria in the urine. If you have difficulty fully emptying your bladder on your own after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.

For more information refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see BOTOX®fullProduct Information, includingBoxed Warning andMedication Guide.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About UBRELVY® (ubrogepant) in the United States

UBRELVY® (ubrogepant) is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine with or without aura in adults that is an option for a wide range of patients who experience migraine attacks. UBRELVY® is the first pill of its kind to directly block CGRP, a protein released during a migraine attack, from binding to its receptors.

IMPORTANT SAFETY INFORMATION

Who should not take UBRELVY® (ubrogepant)?

Do not take UBRELVY® if you are taking medicines known as strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin, itraconazole.

What should I tell my healthcare provider before taking UBRELVY®?

Tell your healthcare provider about all your medical conditions, including if you:

• Have liver problems
• Have kidney problems
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider can tell you if it is safe to take UBRELVY® with other medicines.

What are the most common side effects of UBRELVY®?

The most common side effects are nausea (4%) and sleepiness (3%). These are not all of the possible side effects of UBRELVY®.

What is UBRELVY® (ubrogepant)?

UBRELVY® is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. UBRELVY® is not used to prevent migraine headaches.

Please see full Prescribing Information.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Migraine

Impacting one billion people worldwide, migraine is a neurological disease with recurring attacks that causes pain and other disabling symptoms. However, migraine can be treatable. At AbbVie, we are committed to empowering people in their pursuit of migraine freedom. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments and reclaim their lives.

About AbbVie in Neuroscience

At AbbVie, our commitment to preserve the personhood of those living with neurological and psychiatric disorders is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions for patients, care partners and clinicians. AbbVie’s Neuroscience portfolio consists of approved therapies and a robust pipeline in neurological and psychiatric disorders, including Alzheimer’s disease, bipolar I disorder, major depressive disorder, migraine, Parkinson’s disease, spinal cord injuries, post-stroke spasticity, schizophrenia, stroke and others.

We have a strong investment in neuroscience research, with our Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience Discovery site in Ludwigshafen, Germany, where our research and resilience in these challenging therapeutic areas is yielding a deeper understanding of the pathophysiology of neurological and psychiatric disorders, and identifying targets for potential disease-modifying therapeutics aimed at making a difference in people’s lives.

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @AbbVie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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SOURCE AbbVie