FDA Approves Zavegepant Nasal Spray for Acute Migraine

Megan Brooks

March 14, 2023

The US Food and Drug Administration (FDA) has approved zavegepant (Zavzpret, Pfizer), the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults.

The FDA approved zavegepant nasal spray for the acute treatment of migraine based on two randomized, double-blind, placebo-controlled studies.

In the pivotal phase 3 study, published last month in The Lancet Neurology, intranasal zavegepant was statistically superior to placebo on the coprimary endpoints of pain freedom and freedom from the most bothersome symptom at 2 hours after dosing.

Additionally, zavegepant provided relief from migraine pain in as early as 15 minutes, with relief lasting up to 48 hours for many patients.

"Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works," Kathleen Mullin, MD, with the New England Institute for Neurology and Headache in Stamford, Connecticut, said in a news release from Pfizer.

"As a nasal spray with rapid drug absorption, Zavzpret offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly," said Mullin.

Zavegepant was well tolerated in clinical trials. No serious adverse events were reported.

The most common adverse reactions that were reported in at least 2% of patients treated with the third-generation CGRP receptor agonist that occurred at a frequency greater than with placebo were taste disorders (dysgeusia and ageusia), nausea, nasal discomfort, and vomiting.

Zavegepant is contraindicated in patients who have a history of hypersensitivity to zavegepant or to any of its components. Hypersensitivity reactions, including facial swelling and urticaria, have occurred with zavegepant in clinical trials.

Zavegepant nasal spray is expected to be available this July.

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