Biohaven Pharmaceutical announced a successful end of Phase 2 clinical and nonclinical interaction with the U.S. Food and Drug Administration (FDA) for intranasal vazegepant for the acute treatment of migraine. The Company addressed all issues raised by the FDA and will advance the 10 mg dose of intranasal vazegepant into a double-blind, placebo-controlled Phase 3 clinical trial. Biohaven previously reported that intranasal vazegepant 10 and 20 mg achieved statistical superiority to placebo on the co-primary regulatory endpoints of pain freedom and freedom from most bothersome symptom at 2 hours in a Phase 2/3 dose finding trial.

"Based on this positive interaction with the FDA, we look forward to advancing our Phase 3 clinical trial of intranasal vazegepant 10 mg for the acute treatment of migraine mid-year. If approved, this novel intranasal formulation of vazegepant will complement our recently approved, NURTEC™ ODT (rimegepant) orally disintegrating tablet, currently marketed for acute treatment of migraine and could add another innovative treatment option to help those suffering with migraine obtain rapid relief."  Dr. Coric added, "Biohaven has built a world-class field sales team that is fully equipped to deliver on our entire pipeline and if this planned Phase 3 trial is positive, we would have the potential of filing a New Drug Application (NDA) next year," Vlad Coric, M.D., Chief Executive Officer of Biohaven said.

Vazegepant is the newest member of Biohaven's NOJECTION™ Migraine Platform to have demonstrated efficacy in a pivotal trial. On February 27, 2020, the FDA approved NURTEC ODT orally disintegrating tablets 75 mg for the acute treatment of migraine in adults. Biohaven believes that intranasal vazegepant will be complementary to other calcitonin gene-related peptide-targeting agents, including NURTEC ODT.

"We are pleased to successfully complete our end of Phase 2 meeting with the FDA so that we can continue to advance the development of intranasal vazegepant. In the prior clinical trial, intranasal vazegepant showed evidence of rapid onset with pain relief as early as 15 minutes, return to normal function at 30 minutes and sustained benefits through 48 hours. Patients with migraine deserve multiple therapeutic options to better treat their migraines and return to their daily lives," Robert Croop, M.D., Biohaven's Chief Development Officer – Neurology said.

Nearly 40 million people in the U.S. suffer from migraine and the World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a significant unmet need for new acute treatments as more than 90 percent of migraine sufferers are unable to work or function normally during an attack.

Small molecule calcitonin gene-related peptide (CGRP) receptor antagonists represent a novel class of drugs for the treatment of migraine. This unique mode of action offers an alternative to other treatments, particularly for patients who have contraindications to the use of triptans, those who have a poor response to triptans, or are intolerant to them.

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