The FDA has approved Pfizer’s Zavzpret, a calcitonin gene-related peptide receptor antagonist nasal spray to treat migraine with or without aura in adults.

According to a company press release, approval was based on results of two randomized, double-blind, placebo-controlled studies that established the safety, efficacy and tolerability profiles of the intranasal therapeutic. In these studies, Zavzpret (zavegepant) was superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptoms at 2 hours post-dose. The drug also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint compared with placebo.

“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,” Angela Hwang, MBA, chief commercial officer and president of global biopharmaceuticals business at Pfizer, stated in the release.

Zavzpret was well-tolerated in these trials, per the release, with the most common adverse reactions of taste disorders, nausea, nasal discomfort and vomiting reported in at least 2% of trial participants. Hypersensitivity reactions, including facial swelling and urticaria, have also been reported.

According to Pfizer, Zavzpret is expected to be available in pharmacies in July 2023.