Biohaven Pharmaceutical's rimegepant featured in 16 presentations at AHS meeting
Biohaven Pharmaceutical will present 16 scientific presentations highlighting new efficacy and safety data for rimegepant from Biohaven's clinical development program at the American Headache Society Annual Scientific Meeting in Philadelphia, July 11-14. Biohaven will be presenting results from the rimegepant Zydis oral fast-dissolve tablet Phase 3 trial, new analyses across the three Phase 3 trials, results from the rimegepant long-term safety study, and new clinical pharmacology data. Rimegepant is an oral, single dose, selective and potent small molecule calcitonin gene-related peptide receptor antagonist in development for the acute treatment of migraine. Consistent with the two previous Phase 3 clinical trials for rimegepant oral tablet, Study 303 met its co-primary endpoints of pain freedom and freedom from the most bothersome symptom at two hours using a single dose. Importantly, patients treated with the rimegepant Zydis ODT formulation began to experience pain relief as early as 15 minutes, with numerical separation from placebo, and this difference was statistically significant at 60 minutes. Additionally, a significantly greater percentage of patients treated with rimegepant Zydis ODT returned to normal functioning by 60 minutes as compared to placebo. Sustained clinical benefit was observed through 48 hours after a single dose of rimegepant. The co-primary endpoints achieved in all three Phase 3 trials are consistent with regulatory guidance from the FDA for NDA submissions.