Rimegepant Orally Dissolving Tablet Beneficial in Phase 3 Migraine Trial
Based on the results of the three pivotal Phase 3 trials, the Company plans to submit a New Drug Application to the Food and Drug Administration sometime in the first half of 2019.
Positive topline results were announced from a Phase 3 trial evaluating the safety and efficacy of rimegepant Zydis orally dissolving tablet (ODT) (Biohaven) for the acute treatment of migraine.
In Study 303 (N=1375), rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, achieved statistical significance in 2 co-primary endpoints: pain freedom and freedom from most bothersome symptom (MBS). Results showed that at the 2 hour endpoint, 21.2% of patients treated with rimegepant (N=669) achieved pain freedom compared with 10.9% of the placebo group (N=682) (difference 10.3%; P<.0001). In addition, 35.1% of rimegepant-treated patients reported freedom from MBS (ie, photophobia, phonophobia, nausea) 2 hours post-dose vs 26.8% for placebo (difference 8.3%; P=.0009). For patients treated with rimegepant, lasting clinical benefits (ie, freedom from pain, pain relief, freedom from MBS, freedom from functional disability) were seen 48 hours after a single dose. Moreover, compared with placebo, a significantly greater percentage of patient in the rimegepant group returned to normal functioning by 60 minutes (P=.0025).
With regard to safety, adverse events observed in Study 303 were consistent with those seen in the 2 other trials of rimegepant (Studies 301 and 302); pooled safety data showed that the overall rates of adverse events with rimegepant were similar to placebo across all 3 studies.
“Rimegepant Zydis ODT formulation is rapidly absorbed and has a long half-life,” said Richard B. Lipton, MD, Professor and Vice Chair of Neurology, and Director of the Montefiore Headache Center, at the Albert Einstein College of Medicine. “If approved, rimegepant could potentially play an important role in helping people with migraine find relief from their pain and get back to what they need to do in their lives."
Based on the results of the three pivotal Phase 3 trials, the Company plans to submit a New Drug Application to the Food and Drug Administration sometime in the first half of 2019. Additional outcome measures are expected to be presented at upcoming scientific meetings.
For more information visit biohavenpharma.com.