Highlights from

AAN 2019

American Academy of Neurology annual meeting

Philadelphia, USA 4-10 May 2019

Rimegepant: fast onset and placebo-like tolerability in acute migraine

A single dose of rimegepant orally dissolving tablet (ODT) demonstrated rapid and sustained clinical benefits within 60 minutes and through 48 hours postdose in a multicentre phase 3 trial [1]. The results suggest that rimegepant ODT has a fast onset in the treatment of acute migraine and placebo-like tolerability, including liver function tests.

Rimegepant is a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, which had already demonstrated efficacy in acute migraine. In the trial that was presented at the AAN 2019 meeting, an ODT formulation with a Tmax 30 minutes earlier than the previously studied tablet was tested in the hope of a more rapid onset of action. The 1,375 subjects were randomised to rimegepant 75 mg ODT or placebo, with which they treated 1 migraine attack of moderate or severe pain intensity. The coprimary endpoints were freedom from pain after 2 hours, and freedom from the most bothersome symptom (MBS). A total of 1,351 subjects were evaluated for efficacy. Rimegepant ODT was superior to placebo for 2-hour pain freedom; 21.2% vs 10.9%, (P<0.0001), and freedom from the MBS: 35.1% vs 26.8% (P=0.0009). Rimegepant ODT also significantly outperformed placebo for:

  • 60-minute pain relief (P=0.0314) and functional disability freedom (P=0.0025);
  • 90-minute pain freedom (P<0.0001) and MBS freedom (P=0.0128);
  • 48-hour sustained pain freedom (P<0.0001);
  • sustained pain relief (P<0.0001);
  • sustained MBS freedom (P=0.0018); and
  • sustained functional disability freedom (P<0.0001).

The safety profile was similar to placebo. The most common adverse events were nausea and urinary tract infection, occurring in ≤1.6% of patients. No serious treatment-emergent adverse events were observed.

  1. Lipton RB, Coric V, Stock E, et al. Efficacy, Safety, and Tolerability of Rimegepant 75 mg Orally Dissolving Tablet for the Acute Treatment of Migraine: Results from a Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial, Study 303. AAN 2019, Emerging Science 005.

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