Biohaven Announces Successful Achievement of Both Co-Primary Regulatory Endpoints in Two Pivotal Phase 3 Trials of Rimegepant an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine
March 26, 2018
NEW HAVEN, Connecticut — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced positive top-line results from both of its two Phase 3 clinical trials (BHV3000- 301 and BHV3000-302) of rimegepant (formerly known as BHV-3000), an oral CGRP receptor antagonist for the acute treatment of migraine. In each trial, rimegepant met the co-primary efficacy endpoints of superiority to placebo, at two hours post-dose, on pain freedom and freedom from the most bothersome symptom (MBS) (Figure 1, Table 1). Even without additional rimegepant dosing, or use of rescue medications, these studies showed an early separation from placebo and a profile of continued improvement over the dosing interval. Overall, efficacy and safety results were consistent across both Phase 3 trials.