The Food and Drug Administration (FDA) has approved Zavzpret™ (zavegepant) nasal spray, a calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine with or without aura in adults.
The approval was based on data from 2 double-blind, placebo-controlled studies (ClinicalTrials.gov Identifier: NCT04571060, NCT03872453) that evaluated the efficacy and safety of zavegepant in adults with at least a 1-year history of migraine (with or without aura) and migraine attacks lasting, on average, 4 to 72 hours if untreated. In both trials, patients were randomly assigned to receive a single intranasal dose of zavegepant or placebo.
Results from both studies showed that treatment with zavegepant was statistically superior to placebo on the coprimary endpoints of pain freedom and freedom from most bothersome symptom (nausea, photophobia, phonophobia) at 2 hours.
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In the pivotal phase 3 study, zavegepant was also found to be statistically significantly superior to placebo for the additional efficacy endpoints of pain relief at 2 hours post-dose, return to normal function at 2 hours post-dose, sustained pain freedom from 2 to 48 hours post-dose, and phonophobia and photophobia freedom at 2 hours post-dose.
The most common adverse reactions reported with zavegepant were taste disorders, nausea, nasal discomfort, and vomiting.
Zavzpret nasal spray is supplied as a carton of 6 units with a ready-to-use, unit-dose disposable device; each unit contains 10mg of zavegepant. The maximum dose that may be given in a 24-hour period is 10mg (1 spray). The safety of treating more than 8 migraines in a 30-day period has not been established.
The product is expected to be available in July 2023.
References
- Pfizer’s Zavzpret™ (zavegepant) migraine nasal spray receives FDA approval. News release. Pfizer Inc. Accessed March 10, 2023. https://www.businesswire.com/news/home/20230309005795/en/Pfizer%E2%80%99s-ZAVZPRET%E2%84%A2-zavegepant-Migraine-Nasal-Spray-Receives-FDA-Approval.
- Zavzpret. Package insert. Pfizer Inc; 2023. Accessed March 10, 2023. https://labeling.pfizer.com/ShowLabeling.aspx?id=19471.
This article originally appeared on MPR
