Pfizer has announced the US Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant) - "the first and only" calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults.
In its pivotal Phase 3 study, 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, according to Pfizer. The pivotal study also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint versus 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,” said Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer.
“ZAVZPRET underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives. Pfizer will continue to build its migraine franchise to further support the billions of people worldwide impacted by this debilitating disease.”
ZAVZPRET is anticipated to be available in pharmacies in July 2023.
World’s first migraine nasal spray granted FDA approval
