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

Objective: This pooled analysis of data from four randomized placebo-controlled trials summarizes the efficacy and safety of rimegepant for acute treatment of migraine.

Methods: 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 hours if untreated. Participants were provided with a single dose of rimegepant 75 mg or placebo to treat a single migraine attack of moderate or severe pain intensity within the next 45 days. Co-primary endpoints at 2 hours post-dose were pain freedom and freedom from the most bothersome symptom (MBS). Treatment comparisons utilized Mantel-Haenszel risk estimation with stratification by study and prophylactic migraine medication use randomization stratum; p values are nominal. On-treatment adverse events (AEs) were also assessed.

Results: Overall, 4,895 participants received rimegepant (n = 2,439) or placebo (n = 2,456). For the co-primary endpoints, the proportion of participants with pain freedom 2 hours post-dose (20.0% vs. 11.8%; p < 0.0001) and MBS freedom 2 hours post-dose (40.2% vs. 29.2%; p < 0.0001) was higher in the rimegepant vs. the placebo group. Rimegepant also demonstrated improvements over placebo in nearly all secondary and exploratory efficacy endpoints. AEs were reported in 11.1% and 9.6% of participants in the rimegepant and placebo groups, respectively. The only AE reported in > 1% of participants was nausea (rimegepant = 1.4%, placebo = 1.3%). Severe AEs occurred in 0.3% and 0.1% of participants in the rimegepant and placebo groups, respectively. Serious AEs occurred in 0.1% of participants in both groups; none were deemed related to study treatment.

Conclusion: In this pooled analysis of four randomized placebo-controlled trials, a single dose of rimegepant 75 mg demonstrated efficacy and a favorable safety profile for the acute treatment of a migraine attack with moderate or severe pain.