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.
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.
Pfizer: Innovations That Change Patients’ Lives
At Pfizer, they apply science and their global resources to bring therapies to people that extend and significantly improve their lives. They strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with their responsibility as one of the world’s premier innovative biopharmaceutical companies, they collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, they have worked to make a difference for all who rely on them. They routinely post information that may be important to investors on their website at www.pfizer.com.