Zavzpret Now Available in US Pharmacies as a Nasal Spray Treatment for Migraine

Zavzpret (zavegepant; Pfizer, New York, NY), a nasal spray that treats migraine, is now available in US pharmacies as a package of 6 single-use, disposable devices that deliver a 10 mg dose. The Food and Drug Administration (FDA) approved Zavzpret in March 2023 for the treatment of acute migraine with or without aura in adults. It is the first intranasal-administered small molecule calcitonin gene-related peptide (CGRP) receptor antagonist to be approved for migraine treatment.

FDA approval for Zavzpret was based on data from a phase 2/3 (NCT03872453) and a phase 3 (NCT04571060) randomized, double-blind placebo-controlled clinical trial, which investigated the safety, tolerability, and efficacy of the drug as a treatment for acute migraine. In both studies, results showed that 2 hours after administration, Zavzpret was superior to placebo in reducing pain and other migraine-associated symptoms (photophobia, nausea, phonophobia). The most common adverse reactions were taste disorders, nausea, nasal discomfort, and vomiting.

Only a single, 10 mg dose spray of Zavzpret should be used in any 24-hour period. The drug should not be used in patients with previous hypersensitivity reaction to Zavzpret or its components, in patients with creatine clearance less than 30 mL/min, or in patients with severe hepatic impairment. Use of Zavzpret in combination with OATP1B3 inhibiting drugs, NTCP transporting drugs, and nasal decongestants should be avoided.