New formulation of rimegepant: fast onset of action

The calcitonin gene-related peptide receptor antagonist rimegepant had already demonstrated efficacy in acute migraine. An orally dissolving tablet (ODT) formulation with a more rapid onset of action compared with the previously studied tablet was tested in a multicentre phase 3 trial. A single dose of rimegepant ODT demonstrated rapid and sustained clinical benefits within 60 minutes and through 48 hours post-dose [1]. Tolerability was comparable to placebo, including liver function tests.

This so-called Study 303 randomised 1,375 subjects 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 of pain after 2 hours, and freedom from the most bothersome symptom. 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 most bothersome symptom (35.1% vs 26.8%; P=0.0009). Rimegepant ODT also significantly outperformed placebo for secondary endpoints like 60-minute pain relief, 48-hour sustained pain freedom, and (sustained) functional disability freedom. The most common adverse events were nausea and urinary tract infection, occurring in ≤1.6% of patients. There were no serious treatment-emergent adverse events.

1. Lipton RB, et al. AAN 2019, emerging science 005.



Posted on 30 July 201915 March 2021