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FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine.
On March 10, 2023, Pfizer announced that FDA approved ZAVZPRET (zavegepant), which, according to a company press release, is the first and only calcitonin gene-related peptide receptor antagonist nasal spray for migraine. The drug is approved for the acute treatment in adults of migraine with or without aura.
FDA’s approval is based on two pivotal randomized, double-blind, placebo-controlled Phase III studies that established the drug’s efficacy, tolerability, and safety profiles. The results showed that ZAVZPRET was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose. Study results also demonstrated that pain relief was achieved as early as 15 minutes in a prespecified secondary endpoint versus placebo. Following approval, the drug is expected to be available in pharmacies in July 2023.
“The FDA approval of ZAVZPRET marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” said Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer, in the press release.
“Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works,” said Kathleen Mullin, associate medical director at New England Institute for Neurology & Headache. “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.”