165 Efficacy and safety of rimegepant for the acute treatment of migraine in Japan

a:2:{s:4:"lang";s:2:"en";s:7:"content";s:1452:"<h3>Objective</h3> This randomized, double-blind, phase 2/3 trial evaluated rimegepant for acute treatment of migraine in participants living in Japan. <h3>Methods</h3> Participants treated a single migraine attack of moderate or severe pain intensity with rimegepant 25 mg, rimegepant 75 mg, or placebo. Primary endpoint was participants (%) with pain freedom at 2 h postdose; secondary endpoints included pain relief, most bothersome symptom freedom, return to normal function (all at 2 h postdose), and sustained pain relief and sustained pain freedom (each through 2–24 and 2–48 h postdose). Formal hypothesis testing was conducted for rimegepant 75 mg vs placebo. Adverse events (AEs) were assessed. <h3>Results</h3> 706 treated participants were evaluated. Response rates for the primary endpoint were 21.0% (rimegepant 25 mg), 32.4% (rimegepant 75 mg), and 13.0% (placebo); difference for rimegepant 75 mg vs placebo = 19.4% [95% CI 12.0, 26.8], p&lt;0.0001). Secondary endpoint findings were consistent with the primary endpoint. Any on-treatment AEs were experienced by 7.1% (rimegepant 25 mg), 9.2% (rimegepant 75 mg) and 6.6% (placebo) of participants. <h3>Conclusions</h3> Rimegepant 75 mg demonstrated efficacy superior to placebo for acute treatment of migraine, with a favourable safety profile, in participants in Japan. A dose-response relationship was observed for rimegepant. grant.oneil{at}pfizer.com ";}