Efficacy and safety of rimegepant 75 mg for acute treatment of migraine: a pooled analysis of four randomized, placebo-controlled trials

This pooled analysis of data from four randomizedplacebo-controlled trials summarizes the efficacy and safety of rimegepant foracute treatment of migraine. In all studies, participants were aged ≥18 years and had a ≥ 1-year history of migraine,two to eight migraine attacks of moderate or severe pain intensity per month,and attacks lasting 4–72 hoursif untreated. Participants were provided a single dose of rimegepant 75 mg orplacebo to treat a single migraine attack of moderate or severe pain intensitywithin the next 45 days. Co-primary endpoints at 2 hours post-dose were painfreedom and freedom from the most bothersome symptom (MBS). Treatmentcomparisons utilized Mantel-Haenszel risk estimation with stratification bystudy and prophylactic migraine medication use randomization stratum; <i>p</i>values are nominal. On-treatment adverse events (AEs) were also assessed. Overall, 4,895 participants received rimegepant (<i>n</i> = 2,439) orplacebo (<i>n</i> = 2,456). For the co-primary endpoints, the proportions ofparticipants with pain freedom 2 hours post-dose (20.0% vs. 11.8%; <i>p</i> &lt; 0.0001)and MBS freedom 2 hours post-dose (40.2% vs. 29.2%; <i>p</i> &lt; 0.0001) were higherin the rimegepant vs. the placebo group. Rimegepant also demonstratedimprovements over placebo in nearly all secondary and exploratory efficacyendpoints. AEs were reported in 11.1% and 9.6% of participants in therimegepant and placebo groups, respectively. The only AE reported in &gt; 1% ofparticipants was nausea (rimegepant = 1.4%, placebo = 1.3%). Severe AEs occurred in0.3% and 0.1% of participants in the rimegepant and placebo groups,respectively. Serious AEs occurred in 0.1% of participants in both groups; nonewere deemed related to study treatment. In this pooled analysis of four randomized placebo-controlledtrials, a single dose of rimegepant 75 mg demonstrated efficacy and a favorablesafety profile for the acute treatment of a migraine attack with moderate orsevere pain.