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Abstract Details

Rimegepant 75 mg for the Acute Treatment of Migraine in Adults With Frequent Migraine: Long-Term Safety and Clinical Improvement Versus Baseline
Headache
Headache Posters (7:00 AM-5:00 PM)
014

Rimegepant is an orally administered small molecule CGRP receptor antagonist FDA-approved for acute treatment of migraine. While Phase 3 efficacy trials of rimegepant excluded subjects with ≥15 headache days/month, the rimegepant long-term safety study did not.

Evaluate long-term safety and clinical improvement with rimegepant in adults with frequent migraine.

This was a multicenter, long-term, open-label safety study (NCT03266588) that included adults with a history of 2-14 monthly migraine attacks of moderate to severe intensity. Subjects with chronic migraine were allowed, and there were no limitations on the number of monthly migraine or non-migraine headache days subjects had prior to enrollment. The study included a 30-day observation period followed by a long-term treatment period in which subjects used rimegepant 75 mg orally up to once daily for up to 52 weeks. Migraine days were captured via electronic diary and reported as mild, moderate, or severe. This post-hoc subgroup analysis assessed safety and clinical global impression of change (CGI-C; 7-point rating scale) in subjects experiencing ≥15 migraine days of any severity per 30-days in the observation period.

Of the 1800 treated subjects, 246 (13.7%) experienced ≥15 migraine days per 30 days in the observation period. In this subgroup, the most common adverse events (AEs) were nasopharyngitis (8.5%), sinusitis (6.1%), and upper respiratory tract infection (5.3%). The rate of rimegepant discontinuation due to AEs was 4.9%. Serious AEs occurred in 3.7% of subjects; none were considered by the investigator to be related to rimegepant. Percentages (95% CI) of subjects who were considered improved since study entry on the CGI-C scale, were 89% (83.3, 93.2) and 87.5% (80.0, 92.5) at week 24 (n=157) and week 52 (n=112), respectively.

Long-term dosing of rimegepant 75 mg up to once daily in adults with frequent migraine was safe and well tolerated and associated with clinical improvement.

Authors/Disclosures
Kathleen B. Mullin, MD (NEINH)
PRESENTER
Dr. Mullin has received personal compensation in the range of $0-$499 for serving as a Consultant for Vorso. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Mullin has received personal compensation in the range of $0-$499 for serving as a Consultant for Theranica. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biohaven. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Pfizer. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie.
Susan Hutchinson Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alder Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Allergan Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Currax Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for electroCore. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $0-$499 for serving as a Consultant for Lundbeck Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Upsher Smith. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/AbbVie. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven . Susan Hutchinson has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Headache Cooperative of the Pacific . Susan Hutchinson has received publishing royalties from a publication relating to health care.
Timothy *USE ID 123628 Smith (StudyMetrix Research) The institution of Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vorso. The institution of Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Neuropharma. The institution of Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Nocira. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Impel Neuropharma. The institution of Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie/Allergan. The institution of Timothy R. Smith has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurolief. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amgen. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan (Abbvie). Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biohaven. Timothy R. Smith has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. The institution of Timothy R. Smith has received research support from Allergan. The institution of Timothy R. Smith has received research support from Amgen. The institution of Timothy R. Smith has received research support from Biohaven. The institution of Timothy R. Smith has received research support from Charleston Laboratories. The institution of Timothy R. Smith has received research support from Electrocore. The institution of Timothy R. Smith has received research support from Impel Neuropharma. The institution of Timothy R. Smith has received research support from Lilly. The institution of Timothy R. Smith has received research support from Lundbeck (Alder). The institution of Timothy R. Smith has received research support from Satsuma. The institution of Timothy R. Smith has received research support from Theranica. The institution of Timothy R. Smith has received research support from Vorso. The institution of Timothy R. Smith has received research support from Boehringer Ingelheim. The institution of Timothy R. Smith has received research support from Novartis. The institution of Timothy R. Smith has received research support from Novo Nordisk. The institution of Timothy R. Smith has received research support from Teva. The institution of Timothy R. Smith has received research support from Nocira. The institution of Timothy R. Smith has received research support from Aeon Pharmaceuticals. The institution of Timothy R. Smith has received research support from Eliem Pharmaceuticals. Timothy R. Smith has a non-compensated relationship as a Member, Board of Directors with National Headache Foundation that is relevant to AAN interests or activities.
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine) Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has stock in Biohaven. Dr. Lipton has stock in Manistee. Dr. Lipton has stock in Axon. Dr. Lipton has stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.
Christopher Jensen, PharmD (Biohaven Pharmaceuticals) Dr. Jensen has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Dr. Jensen has stock in Biohaven Pharmaceuticals.
Chelsea Leroue Chelsea Leroue has received personal compensation for serving as an employee of Biohaven Pharmaceuticals.
Alexandra Thiry Alexandra Thiry has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Alexandra Thiry has received stock or an ownership interest from Biohaven Pharmaceuticals.
Meghan Lovegren Meghan Lovegren has received personal compensation for serving as an employee of Biohaven Pharmaceutials, Inc.. Meghan Lovegren has stock in Biohaven Pharmaceuticals, Inc..
Charlie Conway Charlie Conway has received personal compensation for serving as an employee of Biohaven Pharmaceuticals Inc. Charlie Conway has received stock or an ownership interest from Biohaven Pharmaceuticals.
Vladimir Coric Vladimir Coric has received personal compensation for serving as an employee of Biohaven. Vladimir Coric has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Bioahven. Vladimir Coric has stock in Biohaven. Vladimir Coric has received intellectual property interests from a discovery or technology relating to health care.
Robert Croop, MD Dr. Croop has received personal compensation for serving as an employee of Biohaven Pharmaceuticals, Inc. Dr. Croop has received personal compensation for serving as an employee of Pfizer Inc.. Dr. Croop has stock in Biohaven Pharmaceutical Holding Co Ltd. Dr. Croop has stock in Biohaven Ltd.. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care.