DUBLIN, April 20, 2018 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company announced today that the company will share 25 presentations at the 70th Annual American Academy of Neurology (AAN) Meeting, including five oral podium presentations. Five presentations will focus on migraine and one will spotlight the clinical trial results evaluating the safety and efficacy of onabotulinumtoxinA in treating lower limb spasticity in children ages 2-16. Results of the Phase 3 ACHIEVE I study of ubrogepant, an investigational oral calcitonin gene-related peptide (CGRP) for acute treatment of migraine, were selected as an emerging science "data blitz" presentation and poster to be presented on April 24th at 5:45 pm PT.
As the leader in migraine research, Allergan will present 16 pieces of data across a spectrum of migraine types, as well as furthering the scientific understanding of these diseases with epidemiology and comorbidity data. Additionally, results from COMPEL (Chronic Migraine OnabotulinumtoxinA Prolonged Efficacy Open Label), a 108-week study designed to evaluate long-term efficacy and safety of onabotulinumtoxinA treatment in Chronic Migraine patients will be presented. Presentations also include additional data in spasticity and movement disorders.
"We're extremely pleased about the wide range of data being presented at AAN that demonstrate Allergan's continued commitment and leadership in neurology and migraine in particular," said David Nicholson, Chief Research and Development Officer, Allergan. "The unmet need in migraine remains a key priority for Allergan, so we're pleased to have ubrogepant recognized for its unique position with investigational data in the emerging CGRP category, and to share long-term data on BOTOX® in Chronic Migraine."
The scheduled times (noted in local Pacific Time) of the presentations and locations are as follows:
Oral presentations include:
Results of the Phase 3 ACHIEVE I Study of Ubrogepant. Authors: Trugman J, et al. Tuesday, April 24th, 6:06 pm.
Migraine Treatment Patterns and Opioid Use Among Chronic and Episodic Migraine Patients Identified by a Clinician-Administered Semi-Structured Diagnostic Interview. Authors: Pavlovic JM, et al. Wednesday, April 25th, 1:00 pm.
Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Pediatric Lower Limb Spasticity: Primary Results. Authors: Kim H, et al. Wednesday, April 25th, 2:12 pm.
Evaluation of the Identify Chronic Migraine (ID-CM) Screener in a Large Medical Group. Authors: Yu JS, et al. Thursday April 26th, 3:54 pm.
The Relationship Between Sleep Disorders and Migraine: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Buse D, et al. Thursday, April 26th, 4:42 pm.
The following posters will be on display on Tuesday, April 24th from 11:30 am-7:00 pm:
Identifying Natural Subgroups of Migraine Based on Profiles of Comorbidities and Concomitant Conditions: Results of the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Lipton R, et al.
Medical Comorbidities of Migraine: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Manack Adams A, et al.
The Relationship Between Pain, Psychiatric, and Endocrine/Neurological Comorbidities of Migraine: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Authors: Manack Adams A, et al.
Productivity Loss and Indirect Costs of Chronic Migraine and Episodic Migraine in a Commercially-Insured Population. Authors: Yu JS, et al.
Development of a Claims-based Algorithm for Use in Patients with Migraine to Identify Potentially Undiagnosed Chronic Migraine Patients. Authors: Pavlovic JM, et al.
The following presentations will be on display on Wednesday, April 25th from 11:30 am-7:00 pm:
Long-Term Safety and Tolerability of OnabotulinumtoxinA Treatment in Chronic Migraine Patients: COMPEL Analysis by Treatment Cycle. Authors: Brin M, et al.
Effects of OnabotulinumtoxinA Treatment on Disability and Quality of Life in Patients with Chronic Migraine with Baseline Allodynia: A COMPEL Subanalysis. Authors: Young W, et al.
Effects of OnabotulinumtoxinA Treatment on Disability and Quality of Life in Patients with Chronic Migraine with Baseline Headache Every Day: A COMPEL Subanalysis. Authors: Lopez J, et al.
A Multicenter, Prospective, Randomized, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of OnabotulinumtoxinA and Topiramate for Headache Prophylaxis in Adults with Chronic Migraine: The FORWARD Study. Authors: Rothrock J, et al.
Real-Life Use of OnabotulinumtoxinA for the Symptomatic Treatment of Chronic Migraine: The Repose Study. Authors: Ahmed F, et al.
Effects of OnabotulinumtoxinA Treatment on Chronic Migraine Comorbidities of Depression and Anxiety: Psychiatric Comorbidities Responder Analysis. Authors: Blumenfeld A, et al.
The Effects of OnabotulinumtoxinA Treatment on the Chronic Migraine Comorbidities of Sleep and Fatigue. Authors: Blumenfeld A, et al.
Treatment Patterns for Newly Diagnosed Chronic Migraine Patients in a Large US Health Insurer's Population. Authors: Shewale A, et al.
Spasticity and Movement Disorders
The following presentations will be on display on Thursday, April 26th from 11:30 am-7:00 pm:
Comparison of OnabotulinumtoxinA Utilization and Effectiveness Across Various Etiologies of Spasticity from the Adult Spasticity International Registry Study: ASPIRE. Authors: Francisco GE, et al.
The Adult Spasticity International Registry (ASPIRE) Study: Real-World Treatment Utilization and Effectiveness of OnabotulinumtoxinA in Post-Stroke Patients Treated for Spasticity. Authors: Bavikatte G, et al.
Cervical Dystonia Patients Treated with OnabotulinumtoxinA Report Improvements in Health-Related Quality of Life in a Multicentre, Prospective, Observational Study: POSTURe. Authors: Petitclerc M, et al.
BOTOX® (onabotulinumtoxinA) Important Information
BOTOX® is a prescription medicine that is injected 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.
It is not known whether BOTOX® is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
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, 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.
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®; had an allergic reaction to any other botulinum toxin product; have a skin infection at the planned injection site. Serious and/or immediate allergic reactions have been reported. Get medical help right away if you experience symptoms; further injection of BOTOX® should be discontinued. Tell your doctor about all your muscle, nerve and medical conditions. Tell your doctor about all the medicines you take. Using BOTOX® with certain other medicines may cause serious side effects. The most common side effects include neck pain and headache.
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.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.
Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; uncertainty associated with financial projections, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.