Pfizer’s ZAVZPRET (zavegepant) Migraine Nasal Spray received FDA approval

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On Mar. 10, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ZAVZPRET (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults.

In its pivotal Phase 3 study, 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.

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