FDA Accepts NDA for Nasal Migraine Treatment

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for the first quarter of 2023 for zavegepant, a nasal spray for the acute treatment of patients with migraine.

The FDA has accepted for the new drug application (NDA) of Biohaven’s zavegepant nasal spray for the acute treatment of migraine in adults. The Prescription Drug User Fee Act (PDUFA) goal date for completion for the first quarter of 2023.

Zavegepant a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist in an intranasal formulation. If approved it would be the only receptor antagonist in an intranasal formulation, providing pain relief in 15 minutes that lasts through 48 hours after a single dose.

The application is based on two pivotal double-blind, placebo-controlled studies that showed that zavegepant was better than placebo on the coprimary regulatory endpoints of superiority to placebo at two hours for pain freedom and freedom from the migraine-associated most bothersome symptom. 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).

“Zavegepant nasal spray will be an important option for patients seeking nonoral therapies and faster 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, said in a press release. “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.”

Zavegepant is a third-generation small molecule CGRP receptor antagonist from Biohaven's migraine platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations.

Biohaven also markets Nurtec and Nurtec ODT (rimegepant), which was approved by the FDA first approved in February 2020 for the acute treatment of migraine in adults.

In May 2022, Pfizer agreed to acquire Biohaven for about $11.6 billion in cash.