FDA Accepts New Drug Application for Zavegepant for Acute Migraine Treatment 

The Food and Drug Administration (FDA) accepted a New Drug Application (NDA) for intranasal zavegepant (Biohaven, New Haven, CT) for acute treatment of migraine. Zavegepant is a nasal spray that provides pain relief as soon as 15 minutes. Pain relief is sustained for as long as 48 hours. The nonoral route also provides a new treatment option for individuals who have migraine attacks with nausea and vomiting. If approved, zavegepant will be the first intranasal drug in the class of gepants, which are antagonists of the calcitonin gene-related peptide (CGRP) receptor. 

Vlad Coric, MD, 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 who experience nausea or vomiting and need a nonoral treatment option. We have generated robust data from 2 intranasal zavegepant pivotal trials that were submitted with our NDA and look forward to bringing this new treatment option to people suffering from migraine."

In 2 pivotal double-blind placebo-controlled studies (NCT04571060, NCT03872453), zavegepant had statistically significant superiority to placebo for freedom from pain and from most bothersome migraine-associated symptom at 2 hours. The most bothersome symptoms were chosen from photophobia, phonophobia, or nausea. Higher rates of pain relief at 15 minutes, return to normal functioning at 30 minutes, and sustained pain freedom at 24 and 48 hours were also significantly higher with zavegepant vs placebo.

Richard B. Lipton, MD, 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."