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Abstract Details

Rimegepant 75 mg Provides Early and Sustained Relief of Migraine With a Single Dose: Results from 3 Phase 3 Clinical Trials
P6 - Poster Session 6 (12:00 PM-1:00 PM)
Rimegepant is a small molecule CGRP receptor antagonist with demonstrated efficacy and safety in the acute treatment of migraine; its relatively long half-life (10-12 h) may provide sustained benefits in acute treatment. Rimegepant 75 mg ODT has a shorter Tmax (1.5 h) than the tablet formulation (1.99 h; P=.0028), suggesting that the ODT may have an earlier onset of action.
Compare rimegepant with placebo for efficacy in the acute treatment of migraine at early (≤2 hours) and sustained (up to 48 hours) endpoints.
Three double-blind, randomized, placebo-controlled, multicenter trials of identical design were conducted in adults with migraine. Subjects were randomized to rimegepant 75 mg tablet (Studies 301 and 302), 75 mg ODT (Study 303), or placebo and instructed to treat 1 migraine attack of moderate to severe pain intensity.
Among 3507 subjects evaluated for efficacy (rimegepant n=1749, placebo n=1758), pooled 2-hour pain relief rates (95% CIs) for rimegepant and placebo were 57.9% (55.6, 60.2) and 43.9% (41.6, 46.2), respectively. A single dose of rimegepant without rescue medication was superior to placebo for sustained pain relief from 2 to 48 hours postdose (37.8% [95% CI 35.5, 40.0] vs 24.0% [95% CI 22.0, 26.0]) and sustained normal function from 2 to 48 hours postdose (22.3% [95% CI 20.3, 24.2] vs 13.7% [95% CI 12.1, 15.3]). Additionally, rimegepant ODT numerically separated from placebo on pain relief beginning at 15 minutes postdose and was significantly superior to placebo at 60 minutes for pain relief (36.8% vs 31.2%, P=.0314) and return to normal function (22.3% vs 15.8%, P=.0025).
In 3 clinical trials, rimegepant was more effective than placebo on efficacy endpoints measured from 2 through 48 hours postdose. Furthermore, rimegepant ODT had an early onset of action demonstrating superiority over placebo on pain relief and return to normal function at 60 minutes postdose.