Abstract Details

Title Rimegepant is Effective for the Acute Treatment of Migraine in Patients Who Have Discontinued or Currently Use Triptans: Results from 3 Phase 3 Clinical Trials

Topic Headache

Presentation(s) P2 - Poster Session 2 (8:00 AM-9:00 AM)

Poster/Presentation
Number 7-003

Objective Compare the efficacy of rimegepant with placebo in the acute treatment of migraine among patients who discontinued or currently use 5-HT1B/1D agonists (triptans).

Background Triptans may be associated with inadequate treatment response, attack recurrence, adverse effects, and contraindications or warnings that may limit their use. Rimegepant, a small molecule CGRP receptor antagonist with a novel and distinct mechanism of action, has demonstrated efficacy and safety in the acute treatment of migraine.

Design/Methods Three double-blind, randomized, placebo-controlled, multicenter trials of identical design were conducted in adults with migraine. Subjects were randomized to rimegepant 75 mg (Studies 301 and 302), 75 mg ODT (Study 303), or placebo and instructed to treat 1 migraine attack of moderate to severe pain intensity. Populations reporting historic use of discontinued triptans or current triptan use were analyzed. Coprimary efficacy endpoints were freedom from pain and the most bothersome symptom (MBS) at 2 hours postdose; secondary endpoints included pain relief at 2 hours postdose.

Results In total, 3507 participants were evaluated for efficacy (rimegepant n=1749, placebo n=1758). About one third of those in the rimegepant (34.2%) and placebo (36.2%) groups had discontinued triptans; 29.2% and 31.8% were current users of triptans, respectively; 12.9% and 14.2% reported both previous discontinuation and current use of triptans (included in both groups for efficacy analysis). In subjects who had discontinued triptans, rimegepant was significantly more effective than placebo for 2-hour pain freedom (20.6% vs 11.8%, p<0.0001); MBS freedom (38.0% vs 23.5%, p<0.0001); and pain relief (61.2% vs 41.1%, p<0.0001). Among current triptan users, rimegepant was also more effective than placebo for 2-hour pain freedom (21.2% vs 8.6%, p<0.0001); MBS freedom (38.2% vs 21.8%, p<0.0001); and pain relief (62.6% vs 42.1%, p<0.0001).

Conclusions Rimegepant 75 mg was effective for the acute treatment of migraine among subjects who previously discontinued triptans and subjects who currently use triptans.

Authors/Disclosures
Robert Croop, MD PRESENTER	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.
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
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.
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.
	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.
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.

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