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 (2114)

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 Conclusions: Rimegepant 75 mg was effective for the acute treatment of migraine among subjects who previously discontinued triptans and subjects who currently use triptans. Disclosure: Dr. Croop has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biohaven Pharamceuticals, Inc.. Dr. Croop has received compensation for serving on the Board of Directors of Biohaven Pharamceuticals, Inc.. Dr. Croop holds stock and/or stock options in Biohaven Pharamceuticals, Inc. which sponsored research in which Dr. Croop was involved as an investigator. Dr. Croop holds stock and/or stock options in Biohaven Pharamceuticals, Inc.. Dr. Jensen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biohaven Pharmaceuticals. Dr. Jensen holds stock and/or stock options in Biohaven Pharmaceuticals. Dr. Thiry has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biohaven Pharmaceuticals, Inc.. Dr. Thiry has received compensation for serving on the Board of Directors of Biohaven Pharmaceuticals, Inc.. Dr. Thiry holds stock and/or stock options in Biohaven Pharmaceuticals, Inc. which sponsored research in which Dr. Thiry was involved as an investigator. Dr. Thiry holds stock and/or stock options in Biohaven Pharmaceuticals, Inc.. Dr. Stock has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biohaven Pharamceuticals. Dr. Stock holds stock and/or stock options in Biohaven Pharmaceuticals. Dr. Conway has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biohaven. Dr. Conway holds stock and/or stock options in Biohaven. Dr. Morris has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biohaven. Dr. Morris holds stock and/or stock options in Biohaven. Dr. Coric has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biohaven Pharmaceuticals, Inc.. Dr. Coric has received compensation for serving on the Board of Directors of Biohaven Pharmaceuticals, Inc.. Dr. Coric holds stock and/or stock options in Biohaven Pharmaceuticals, Inc. which sponsored research in which Dr. Coric was involved as an investigator. Dr. Coric holds stock and/or stock options in Biohaven Pharmaceuticals, Inc.. Dr. Lipton has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Lipton has received compensation for serving on the Board of Directors of eNeura and Biohaven. Dr. Lipton holds stock and/or stock options in Biohaven which sponsored research in which Dr. Lipton was involved as an investigator. Dr. Lipton holds stock and/or stock options in Biohaven. Dr. Lipton has received research support from Migraine Research Foundation the National Headache Foundation and Amgen.