Biohaven Pharmaceutical said that a Phase 3 trial of its intranasal zavegepant (BHV-3500) for the treatment of moderate or severe migraine has met its primary endpoints, demonstrating statistically significant increase in freedom from both pain and most bothersome symptom compared to placebo. This is the second pivotal trial of intranasal zavegepant for migraine; in December 2019, the company announced positive results from a Phase 2/3 trial of the intranasal CGRP receptor antagonist, and Biohaven now says it will move ahead with regulatory submissions in the first quarter of 2022.
The Phase 3 trial enrolled 1,405 adults and evaluated a single dose of BHV-3500 compared to placebo. According to Biohaven, at 2 hours post dose, 40% of subjects who received zavegepant achieved freedom from their most bothersome symptom compared to 31% who received a placebo. Freedom from pain at 2 hours was achieved by 24% in the zavegepant group and 15% in the placebo group. The company also noted that the nasal spray demonstrated superiority to placebo for pain relief at 15 minutes post dose and, patients who achieved freedom or relief from pain had significantly greater sustained relief at 24 and 48 hours. Among patients receiving BHV-3500, 21% reported abnormal taste compared to 5% for placebo.
Biohaven CEO Vlad Coric said, “Intranasal zavegepant was designed to provide ultra-rapid pain relief and expand our CGRP receptor-antagonist franchise by providing patients with another important tool to combat migraine. The trial results clearly show that the performance of this formulation exceeded expectations by demonstrating superiority over placebo on pain relief at 15 minutes and return to normal function by 30 minutes. The impressive efficacy, safety and tolerability profile shown in this trial highlights the potential of zavegepant to usher in a new era of non-oral CGRP targeting migraine therapies that may transcend the traditional boundaries of older legacy intranasal migraine approaches. Biohaven is committed to delivering on its promise to provide new treatment options for the millions of people living with this debilitating disease and these data represent a major milestone in that endeavor.”
Read the Biohaven Pharmaceutical press release.
