The U.S. 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.
The FDA approval is based on data from a late-stage study that showed the drug, when compared to a placebo, proved superior in 13 of 17 goals, including pain relief in 15 minutes, normal function at 30 minutes and return to normal at two hours.
“One of the most important attributes of an acute treatment option is how quickly it works.,” said Kathleen Mullin, M.D., 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.”
Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. For acute treatment, this unique mode of action offers an alternative to other agents, including those patients who have contraindications to the use of triptans or who have a poor response to triptans or are intolerant to them.
ZAVZPRET is anticipated to be available in pharmacies in July 2023.
–Alice Wong, NP