Abstract text (incl. figure legends and references)

Objective

Assess the efficacy of rimegepant — an oral small molecule calcitonin gene-related peptide receptor antagonist — for the acute treatment of migraine in subjects with and without a history of insufficient response to triptans.

Methods

Three double-blind, placebo-controlled trials of similar design randomized adults with migraine to rimegepant 75 mg tablet (NCT03235479, NCT03237845) or ODT (NCT03461757) or placebo to treat 1 migraine attack of moderate to severe pain intensity. Subgroups with a history of insufficient response with 1 or ≥2 triptans and those without a history of insufficient response, including triptan-naïve and current triptan users, were analyzed. Triptan insufficient response was defined as self-reporting a history of discontinuing ≥1 triptan due to inadequate efficacy and/or poor tolerability. The co-primary endpoints were 2-hour freedom from pain and the most bothersome symptom (MBS).

Results

In the pooled population (N=3507: rimegepant n=1749, placebo n=1758), 2272 (64.8%) subjects had no history of triptan insufficient response and 1235 (35.2%) had a history of insufficient response with ≥1 triptan. Results for the co-primary endpoints in each triptan subgroup are shown in Figure 1. No differences in co-primary endpoints were found in pairwise comparisons of triptan subgroups in rimegepant-treated subjects (Figure 2).

Conclusions

Rimegepant was effective for the acute treatment of migraine in subjects with and without a history of triptan insufficient response. The efficacy of rimegepant was consistent among those with insufficient response to 1 or ≥2 triptans and those who were triptan-naïve or currently using triptans.