Biohaven Pharmaceutical Holding Company Ltd. announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review a New Drug Application (NDA) for zavegepant nasal spray, the only small molecule calcitonin gene-related peptide (CGRP) receptor antagonist in an intranasal formulation, for the acute treatment of migraine in adults. The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the NDA is set for 1Q2023.
Vlad Coric, M.D., Chief Executive Officer and Chairman of Biohaven, commented, “People with migraine want an acute treatment that provides fast, lasting relief from the debilitating symptoms of this disease. If approved, zavegepant would provide a new treatment option for patients who need ultra-rapid relief, in as early as 15 minutes, and for those that experience nausea or vomiting and need a non-oral treatment option. We have generated robust data from two intranasal zavegepant pivotal trials that were submitted with our NDA and look forward to bringing this new treatment option to people suffering from migraine.”
The NDA for zavegepant was based on two pivotal double-blind, placebo-controlled studies that established the efficacy, tolerability and safety profile of zavegepant for the acute treatment of migraine. In the pivotal studies, zavegepant was statistically superior to placebo on the coprimary regulatory endpoints of superiority to placebo at 2 hours for pain freedom and freedom from the migraine-associated most bothersome symptom (MBS). In the trials, patients identified their most bothersome symptom other than pain from a list comprised of nausea, heightened sensitivity to light (photophobia) and heightened sensitivity to sound (phonophobia). In the Phase 3 pivotal trial, zavegepant showed broad efficacy by demonstrating statistically significant superiority to placebo across a total of 15 prespecified primary and secondary outcome measures, including multiple ultra-rapid onset endpoints (e.g., 15 minute pain relief and return to normal function in 30 minutes) and multiple durable efficacy endpoints (e.g., 2-24 and 2-48 hour sustained pain freedom and sustained pain relief).
Richard B. Lipton, M.D., Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine and Director of the Montefiore Headache Center, commented, “Many patients with migraine need treatments other than pills for at least some of their attacks. Swallowing a pill may make nausea worse and if the patient vomits, medication cannot be absorbed. Nasal sprays are a favored option to tablets in many situations. In addition, many patients dissatisfied with their current acute treatments want faster relief so they can get back to their plans without missing life’s important moments. Zavegepant nasal spray will be an important option for patients seeking nonoral therapies and faster relief. Though head to head studies are lacking, relative to triptan nasal sprays, zavegepant should provide favorable safety and tolerability, lack of cardiovascular contraindications and precautions and a reduced risk of medication overuse.”
Elyse Stock, M.D., Chief Medical Officer, commented, “In addition to providing new treatment options for everyday heroes at home, work and school, many of the 40 million people in the US with migraine hold high-intensity jobs. When migraine strikes, they need a fast-acting treatment option that enables them to quickly get back to work and keep on working. The zavegepant profile of ultra-rapid 15 minute onset and durable efficacy through 48 hours with a single dose is uniquely well suited to serve people with migraine.”