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NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced publication of results in The Lancet Neurology from the Phase 3 pivotal clinical trial of zavegepant, an investigational calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine. The study met its co-primary endpoints, showing that a single 10 mg dose of zavegepant was more effective than placebo for both pain freedom and freedom from the most bothersome symptom (MBS) at two hours post-dose. Additionally, zavegepant demonstrated relief from migraine pain in 15 minutes, with relief lasting up to 48 hours for many patients. Zavegepant was well tolerated, and there were no serious adverse events reported in treated participants.
“The results from this study demonstrate zavegepant’s potential as an effective acute nasal spray treatment for migraine, a neurological disorder that affects more than one billion people worldwide,” said Richard B. Lipton, M.D., Lead Author, Department of Neurology at the Albert Einstein College of Medicine. “This was the first Phase 3 clinical trial of a non-oral CGRP receptor antagonist developed for the acute treatment of migraine in adults. With this evidence of sustained treatment benefits, good tolerability and an alternative administration method, I believe zavegepant has the potential to fill an important gap in the available options for the acute treatment of migraine.”
In the trial, 1,405 people were randomized to receive a single 10 mg dose of either zavegepant or placebo. Participants historically experienced two to eight moderate or severe migraine attacks per month, and their untreated attacks lasted a mean of 30.8 hours. During the study, participants recorded their migraine headache pain intensity based on a four-point scale, identified their current MBS associated with migraine (selected from phonophobia, photophobia or nausea) and recorded their level of functional disability immediately before dosing the treated attack and at various intervals post-dose.
Zavegepant was demonstrated to be effective in the acute treatment of migraine, as measured by superiority to placebo on the co-primary efficacy endpoints of pain freedom (24% vs 15%, P
