Pfizer’s ZAVZPRET™ nasal migraine spray is the first to be approved by the FDA

Pfizer Inc. has announced that the US Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant) nasal spray for the acute treatment of migraine with or without aura in adults.

Pfizer's ZAVZPRET™ nasal migraine spray is the first to be approved by the FDA 1


This is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray. ZAVZPRET has been proven effective, tolerable, and safe in two pivotal randomized, double-blind, placebo-controlled studies. It was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose. Additionally, ZAVZPRET showed broad efficacy across 13 of 17 prespecified secondary outcome measures, including early time point endpoints, return to normal function at 2 hours, and durable efficacy endpoints. ZAVZPRET will be available in pharmacies in July 2023.

Migraine is a debilitating disease that affects nearly 40 million people in the United States alone, with multiple symptoms that can last for up to 72 hours. CGRP receptor antagonists represent a new class of drugs for migraine treatment that offer an alternative to other agents, including those with contraindications or a poor response to triptans. Importantly, CGRP signal-blocking therapies have not been associated with medication overuse headache or rebound headache, which can limit the clinical utility of other acute treatments.

ZAVZPRET offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting. It is anticipated to be a significant breakthrough for people with migraines who need freedom from pain and prefer alternative options to oral medications. Pfizer aims to continue building its migraine franchise to further support the billions of people worldwide impacted by this debilitating disease.

Zavegepant, the active ingredient in ZAVZPRET, is a third-generation, high-affinity, selective, and structurally unique, small molecule CGRP receptor antagonist, and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. In clinical trials, ZAVZPRET was well tolerated, with the most common adverse reactions being taste disorders, nausea, nasal discomfort, and vomiting. It is contraindicated in patients with a history of hypersensitivity to zavegepant or any of its components. Hypersensitivity reactions have occurred with ZAVZPRET in clinical studies. Finally, ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults and is not indicated for the preventive treatment of migraine.

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