Rimegepant for the Acute and Preventive Treatment of Migraine in Women: Results From 4 Randomized, Placebo-Controlled Clinical Trials
Susan Hutchinson1, Jelena Pavlovic2, Jessica Ailani3, Kathleen Mullin4, Robert Croop5, Alexandra Thiry5, Beth Morris5, Lisa Kamen6, Chandra Abbott5
1Orange County Migraine & Headache Center, 2Albert Einstein College of Medicine, 3Medstar Georgetown Neurology, 4New England Institute for Neurology and Headache, 5Biohaven Pharmaceuticals, 6Biohaven Pharmaceuticals, Inc.
Objective:
Compare the efficacy of rimegepant 75 mg with placebo in the acute and preventive treatment of migraine in women.
Background:

Rimegepant is an orally administered small molecule CGRP receptor antagonist indicated for the acute and preventive treatment of migraine.

Design/Methods:

Post hoc subgroup analyses were conducted using pooled data from 3 double-blind, randomized, placebo-controlled studies of rimegepant 75 mg for acute treatment, and a 12-week, randomized, double-blind, placebo-controlled study of rimegepant 75 mg for preventive treatment in female adults aged ≥18 years with a ≥1-year history of migraine. In the acute treatment trials, the co-primary endpoints were pain freedom and most bothersome symptom (MBS) freedom at 2 hours postdose. In the preventive treatment trial, the primary endpoint was mean change from the 4-week observation period in monthly migraine days (MMDs) in the last 4 weeks of the double-blind treatment phase (weeks 9-12). Treatment groups were compared using nominal p-values.

Results:

In the acute treatment trials, of the 3507 efficacy-evaluable participants, 86% were female (N=3025, rimegepant n=1511, placebo n=1514). Rimegepant was more effective than placebo for 2-hour pain freedom (21.1% vs 12.2%, p<0.0001) and MBS freedom (36.9% vs 26.7%, p<0.0001). In the preventive treatment trial, of the 695 efficacy-evaluable participants, 83% were female (N=577, rimegepant n=282, placebo n=295). Least squares mean changes (SE) from the observation period in MMDs during weeks 9 to 12 were greater on rimegepant −4.5 days (0.25) than placebo −3.7 days (0.25), with least squares mean difference of −0.8 days (95% CI −1.47 to −0.08; p=0.0285).

Conclusions:

Rimegepant 75 mg showed benefits for the acute and preventive treatment of migraine in adult women.

10.1212/WNL.0000000000203969