New Nasal Spray Treatment for Migraine Approved

The Food and Drug Administration (FDA) approved a new nasal spray for the treatment of acute migraine with or without aura in adults. Zavegepant (Zavzpret; Pfizer, New York, NY) represents the first intranasal-administered small molecule calcitonin gene-related peptide (CGRP) receptor antagonist to be approved for migraine treatment. FDA approval was based on results from 2 randomized, double-blind placebo-controlled trials, including a phase 3 study (NCT04571060) on the safety, tolerability, and efficacy of zavegepant for the treatment of acute migraine. Results from this phase 3 study, published in the March issue of The Lancet Neurology, showed that, 2 hours post-dose, a higher percentage of individuals treated with zavegepant 10 mg nasal spray reported more pain freedom and freedom from their most bothersome symptom than those administered a placebo.

According to Kathleen Mullin, MD, Associate Medical Director at New England Institute for Neurology & Headache, “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.”

The most common adverse reactions to zavegepant reported included taste disorders, nausea, nasal discomfort, and vomiting. Zavegepant is contraindicated in those with previous hypersensitivity reaction to zavegepant or its components.

Pfizer reports anticipated availability of the drug in pharmacies in July 2023.