CGRP receptor antagonist, first nasal spray
FDA-approved for acute migraines in adults
rational design based on known CGRP antagonists
FDA approval, March 10, 2023
Bristol Myers Squibb, NY / Pfizer, Inc., NY
The first approved CGRP receptor antagonist nasal spray for the treatment of migraine. Pfizer has announced the FDA-approval of zavegepant (ZAVZPRETTM, BHV-3500) for the treatment of acute migraine in adults based on positive Ph. II/III results. As the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for migraine treatment, zavegepant was statistically superior to placebo on the co-primary endpoints of ‘pain freedom’ and ‘freedom from most bothersome symptom’ at 2 hours after dosing (NCT04408794). This pivotal study also demonstrated pain relief as early as 15 minutes in a secondary endpoint, as compared to placebo. The rapid action for the intranasal delivery and the lack of needing to swallow a pill for relief for migraine patients, especially those…