Abstract Details

Title Rimegepant 75 mg Demonstrates Safety and Tolerability Similar to Placebo With No Effects of Age, Sex, or Race in 3 Phase 3 Trials

Topic Headache

Presentation(s) P7 - Poster Session 7 (5:30 PM-6:30 PM)

Poster/Presentation
Number 7-003

Objective This analysis was conducted to compare the safety and tolerability of rimegepant 75 mg with placebo, including any effects of subject sex, age, and race on safety and tolerability.

Background Most (52%) triptan users experience adverse events, which can cause delays or avoidance of treatment; safety and tolerability issues can be complicated by patient sex, age, and race. Rimegepant is an orally administered small molecule CGRP receptor antagonist that has demonstrated efficacy in the acute treatment of migraine.

Design/Methods Three double-blind, randomized, placebo-controlled, multicenter trials of identical design were conducted in adults ≥18 years of age with ≥1-year history of migraine. Subjects were randomized to rimegepant 75 mg (Studies 301 and 302), 75 mg ODT (Study 303), or placebo and instructed to treat a single migraine attack of moderate or severe pain intensity. Safety assessments included adverse events (AEs), ECGs, vital signs, and routine laboratory tests, including liver function tests. Subjects were grouped by sex, age (<40, ≥40, <65, ≥65), and race for additional analyses of safety.

Results Altogether, 3553 subjects were analyzed for safety (rimegepant n=1771, placebo n=1782). Subjects were 86% female; 88 subjects were ≥65 years of age; and 851 subjects were not Caucasian. Pooled results indicate that rimegepant was well tolerated, with no notable differences in safety based on sex, age, and race. A total of 10.8% (192/1771) and 8.6% (154/1782) of subjects in the rimegepant and placebo groups, respectively, experienced at least 1 on-treatment AE. The most common AEs (≤1.5%) in all subgroups were nausea and urinary tract infection (except males). No serious treatment-related AEs were reported. No liver safety concerns were identified.

Conclusions Pooled results show that the tolerability of rimegepant was similar to placebo, with no liver safety issues and no meaningful differences in safety and tolerability by sex, age, or race.

Authors/Disclosures
Jack D. Schim, MD, F�鶹��ýӳ�� PRESENTER	Dr. Schim has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Aeon, Abbvie, Amgen, Biohaven, electroCore, Impel, Lilly, Lundbeck, Novartis, Promius, Revance, Teva, Upsher-Smith. Dr. Schim has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan, Amgen, Biohaven, electroCore, Lilly, Lundbeck, Novartis, Promius, Teva, Theranica, Upsher-Smith.
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.
Richard B. Lipton, MD, F�鶹��ýӳ�� (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 as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. 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 or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had 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.
Elyse Stock	Elyse Stock has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. An immediate family member of Elyse Stock has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Biohaven Pharmaceuticals. An immediate family member of Elyse Stock has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Flagship Pioneering Management. An immediate family member of Elyse Stock has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol-Myers Squibb. An immediate family member of Elyse Stock has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Optinose. An immediate family member of Elyse Stock has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abpro. An immediate family member of Elyse Stock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Adagio. Elyse Stock has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Biohaven Pharmaceuticals. Elyse Stock has received stock or an ownership interest from Biohaven Pharmaceuticals. An immediate family member of Elyse Stock has received stock or an ownership interest from BIohaven Pharmaceuticals.
	No disclosure on file
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.
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.
	No disclosure on file
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 received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Collima LLC. Dr. Croop has stock in Biohaven Pharmaceutical Holding Co Ltd. Dr. Croop has stock in Biohaven Ltd.. Dr. Croop has stock in Actio Biosciences, Inc. . Dr. Croop has received research support from Pfizer Inc. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care.

�鶹��ýӳ��

�鶹��ýӳ��