The FDA approved zavegepant (Zavzpret, Pfizer) as the first calcitonin gene–related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults.
The FDA approval is based on two pivotal randomized, double-blind, placebo-controlled studies that established the efficacy, tolerability and safety profiles of zavegepant for the acute treatment of migraine. In these studies, zavegepant was statistically superior to placebo on the co-primary