FDA Approves Novel Nasal Spray for Migraine

The FDA has approved Pfizer’s Zavzpret (zavegepant) to treat adult patients with migraine with or without aura. Nearly 40 million people in the United States suffer from migraine. Zavzpret is the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray. It was developed by Biohaven, which Pfizer acquired in October 2022 for $11.6 billion in cash.

Pfizer indicated that pricing of Zavzpret will be available at launch, which is anticipated in July 2023, and is expected to be comparable in price to other FDA approved CGRP migraine medicines. The company is actively engaged with all payers and PBMs to ensure access to zavegepant.

“As a nasal spray with rapid drug absorption, Zavzpret offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly,” Kathleen Mullin, M.D., associate medical director at New England Institute for Neurology & Headache, said in a press release.

The FDA approval is based on two pivotal randomized, double-blind, placebo-controlled studies. In these studies, Zavzpret was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose. The pivotal study also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint versus placebo.

The pivotal phase 3 study published in The Lancet Neurology found Zavzpret showed broad efficacy by also demonstrating statistically significant superiority to placebo across 13 of 17 prespecified secondary outcome measures, including early time point endpoints, return to normal function at 2 hours, and durable efficacy endpoints.

The most common adverse reactions were taste disorders, nausea, nasal discomfort and vomiting.