DUBLIN, May 2, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today that the company will share 29 presentations at the 71st Annual American Academy of Neurology (AAN) Meeting, including 10 oral podium presentations and 14 poster presentations highlighting the company's science and innovation in migraine. Under the company's migraine franchise, Allergan MIND™ (Migraine: Innovation, Navigation, and Discovery) these 24 presentations represent the largest volume of migraine posters and oral podium presentations at this year's meeting. Additional presentations will highlight data from ongoing studies in adult spasticity (upper and lower limb) and Alzheimer's disease.
Remaining at the forefront of migraine research, Allergan will present clinical data across chronic and episodic migraine, further expanding the scientific understanding of these diseases. Data to be showcased from Allergan's migraine pipeline will include safety and tolerability data on its investigational oral CGRP receptor antagonist ubrogepant, for acute treatment, as well as patient-reported outcomes from ACHIEVE I and II clinical trials. Further, data highlighting the efficacy, safety and tolerability of atogepant, the company's second investigational oral CGRP receptor antagonist, for preventive treatment of migraine, will be presented. Allergan's first-line treatment for Chronic Migraine, BOTOX®, will be featured in several presentations focused on safety, efficacy, and healthcare resource utilization, including the FORWARD, REPOSE, PREEMPT and PREDICT studies.
"We're extremely pleased to have a total of 29 presentations including an unprecedented 24 migraine presentations at this year's meeting and be able to showcase our breadth and depth of data in the neurology and migraine space," said David Nicholson, Chief Research and Development Officer, Allergan. "As the migraine treatment landscape continues to expand and become increasingly competitive, Allergan remains focused on the unmet needs in those with migraine, striving towards a better understanding of the disease and innovating to develop impactful migraine treatments. Allergan is proud to remain an industry leader with ubrogepant's recent FDA filing acceptance and potential in the oral CGRP category, and BOTOX® celebrating its 30th anniversary this year since FDA approval of blepharospasm and strabismus in 1989."
The scheduled times (noted in local Eastern Standard Time) of the presentations are as follows:
Oral presentations include:
- Orally Administered Atogepant Was Efficacious, Safe, and Tolerable for the Prevention of Migraine: Results from a Phase 2b/3 Study. Authors: Goadsby P, et al. Monday, May 6th, 1:00 PM.
- Safety and Tolerability of Ubrogepant Following Intermittent, High Frequency Dosing. Authors: Goadsby P, et al. Monday, May 6th, 2:28 PM.
- Characterization of the Effects of the Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonists, Atogepant and Ubrogepant, on Isolated Human Coronary, Cerebral, and Middle Meningeal Arteries. Authors: Rubio-Beltran E, et al. Monday, May 6th, 3:52 PM.
- Reduction in Healthcare Resource Utilization in Patients Treated with OnabotulinumtoxinA for Chronic Migraine: Results from the REPOSE Study. Authors: Kollewe K, et al. Wednesday, May 8th, 2:06 PM.
- Efficacy, Safety, and Tolerability of Ubrogepant for the Acute Treatment of Migraine: Results from a Single-Attack Phase 3 Study, ACHIEVE II. Authors: Trugman J, et al. Wednesday, May 8th, 2:17 PM.
- Life with Migraine, Effect on Relationships, Career and Finances, and Overall Health and Well-Being: Results of the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, Authors: Buse D, et al. Friday, May 10th, 1:11 PM.
- Triptan Discontinuation and Treatment Patterns Among Migraine Patients Initiating Triptan Treatment in a US Commercially Insured Population, Authors: Marcus S, et al. Friday, May 10th, 1:22 PM.
- Demographics, Headache Characteristics, and Other Factors Associated with Opioid Use in People with Migraine: Results from the CaMEO Study, Authors: Lipton R, et al. Friday, May 10th, 1:55 PM.
- Opioid Use, Rebound Headache, and Resource Utilization Among Migraine Patients with Insufficient Response to Triptans Based on Real-World Data, Authors: Silberstein S, et al. Friday, May 10th, 2:06 PM.
- Patterns and Characterization of Acute Prescription Migraine Medication Use: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, Authors: Hutchinson S, et al. Friday, May 10th, 2:17 PM.
The following posters will be on display on Sunday, May 5th from 11:30 am-6:30 pm. *Authors will present from 5:30 - 6:30 pm):
- Single and Multiple Doses of Ubrogepant Are Not Associated with a Clinically Significant Elevation of Alanine Aminotransferase in Healthy Adult Males, Authors: Bondiskey P, et al.
- Absence of Clinically Significant Drug Interactions with Coadministration of Ubrogepant and an Ethinyl Estradiol/Norgestimate Oral Contraceptive in Healthy Female Subjects: A Phase 1 Pharmacokinetic Analysis, Authors: Li C, et al.
- Absence of Clinically Significant Drug Interactions with Coadministration of Atogepant and an Ethinyl Estradiol/Levonorgestrel Oral Contraceptive in Healthy Female Subjects: A Phase 1 Pharmacokinetic Analysis, Authors: Ankrom W, et al.
The following posters will be on display on Monday, May 6th from 11:30 am-6:30 pm:
- Improved Functionality, Pain Relief, and Satisfaction in Patients Treated with Ubrogepant vs Placebo: Results from 2 Single-Attack Phase 3 Studies, ACHIEVE I and II, Authors: Viswanathan H, et al.
- OnabotulinumtoxinA Is Safe and Effective in Patients Who Discontinue Topiramate: Results of the FORWARD Study, Authors: Rothrock J, et al.
- Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine, Authors: Ailani J, et al.
- Early and Sustained Effect of OnabotulinumtoxinA for Chronic Migraine Treatment: Pooled Analysis of PREEMPT Data, Authors: Dodick D, et al.
- Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults, Authors: Jakate A, et al.
- Multiple, Once-Daily, Oral Doses of 150 mg Ubrogepant Administered for 28 Days Are Generally Well Tolerated, with No Clinically Significant Elevation of Alanine Aminotransferase in Healthy Adult Males, Authors: Bondiskey P, et al.
The following posters will be on display on Tuesday, May 7th from 11:30 am-6:30 pm:
- Ubrogepant is Effective for the Acute Treatment of Migraine in Patients with an Insufficient Response to Triptans, Authors: Blumenfeld A, et al.
- Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study Demonstrate a High Level of Unmet Need for Migraine Treatment in People Who Discontinue Acute Prescription Migraine Medication, Authors: Manack Adams A, et al.
The following posters will be on display on Wednesday, May 8th from 11:30 am-6:30 pm:
- Impact of OnabotulinumtoxinA on Quality of Life, Health Resource Utilization, and Work Productivity in People with Chronic Migraine: Interim Results from a Prospective, Observational Study (PREDICT), Authors: Boudreau G, et al.
- Undiagnosed Chronic Migraine Is Associated with Higher Economic Burden Compared with Diagnosed Chronic Migraine: Results from a Claims-Based Retrospective Study, Authors: Marcus S, et al.
- Characterization of Ubrogepant: A Potent and Selective Antagonist of the Human Calcitonin Gene Related Peptide Receptor, Authors: Moore E, et al.
Spasticity and Movement Disorders
The following posters will be on display on Wednesday, May 8th from 11:30 am-6:30 pm:
- Individualized OnabotulinumtoxinA Treatment for Lower Limb Spasticity Resulted in High Patient and Clinician Satisfaction in the ASPIRE Study, Authors: Esquenazi A, et al.
- Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Patient and Clinician Satisfaction in the ASPIRE Study, Authors: Francisco G, et al.
Alzheimer 's Disease
Oral Presentations include:
- The Effects of Memantine Added to Cholinesterase Inhibitors on NPI Behavioral Domains: Pooled Post Hoc Analysis of 3 Randomized Controlled Trials in Patients with Moderate to Severe AD, Authors: Cummings J, et al. Sunday, May 5th 4:47 PM.
The following posters will be on display on Wednesday, May 8th from 11:30 am-6:30 pm:
- Efficacy of Memantine Added to Cholinesterase Inhibitors on SIB Higher-Order Cognitive Domains: Pooled Post Hoc Analysis of 2 Randomized Controlled Trials in Patients with Moderate to Severe AD, Authors: Schmitt F, et al.
- SIB Maintenance of Response with Memantine Added to Cholinesterase Inhibitors: Pooled Post Hoc Analysis of 2 Randomized Controlled Trials in Patients with Moderate to Severe AD, Authors: Schmitt F, et al.
BOTOX® is a prescription medicine that is injected into muscles and used:
- 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 certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and 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).
It is not known whether BOTOX® is safe or effective for other types of muscle spasms.
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 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, 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 its ingredients (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.
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, or 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®.
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®.
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; 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 medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you 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 injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of eyelids, and dry eyes; drooping eyebrows.
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® full Product Information including Boxed Warning and Medication Guide.
Ubrogepant is an orally-administered CGRP receptor antagonist in development for the acute treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. CGRP receptor antagonism is a novel mechanism of action for the acute treatment of migraine that differs from the mechanisms of currently available triptans (serotonin 1B/1D agonists), opioids and ergots.
Atogepant is an orally-administered CGRP receptor antagonist in development for the prevention of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. It is chemically distinct from ubrogepant, our investigational orally-administered CGRP receptor antagonist for the acute treatment of migraine, and has demonstrated in preclinical studies to have a higher potency and longer half-life, making it potentially suitable for preventive treatment.
Migraine is a chronic disease with episodic attacks defined by neurological symptoms such as headache pain, sensitivity to light and sound, and nausea; these symptoms are often incapacitating. Migraine is highly prevalent, affecting approximately 1 in 7 individuals, and is associated with significant disability leading to high personal, family, societal, and economic burden. Despite its prevalence and the availability of treatments, migraine is an underdiagnosed and undertreated disease. There is a need for new treatments for migraine with improved benefit-risk profiles to fulfill this unmet need.
Allergan, a leader in the migraine space, markets BOTOX® (onabotulinumtoxinA) the first FDA-approved, preventive treatment for adult Chronic Migraine patients since it was approved in 2010. Allergan is also advancing its migraine program with two investigational small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists, which are being developed for the acute treatment and prevention of migraine. The U.S. FDA has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults, and a PDUFA date is expected in the fourth quarter of 2019. Ubrogepant is expected to be the first oral CGRP receptor antagonist to market. In addition, atogepant is currently in Phase 3 development for the prevention of migraine.
About Allergan MIND™
As part of Allergan's ongoing commitment to innovating and inspiring change in the migraine community, the company has established a migraine franchise, Allergan MIND™ (Migraine: Innovation, Navigation, Discovery), to drive progress and unify its efforts as a worldwide leader in migraine. Allergan MIND™ represents the company's vision and mission to continue advancing science and improving the lives of people living with migraine disease with treatments, education and support in the pursuit of migraine freedom. This new migraine franchise serves as a center of excellence and catalyst for advancing the dialogue and treatment landscape in migraine, bringing together diverse stakeholders to rally around the latest insights and developments that will impact the future of migraine.
About Allergan plc
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 primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology.
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.
For more information, visit Allergan's website at www.Allergan.com.
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; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, 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, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
Manisha Narasimhan, PhD
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