Biohaven advances intranasal vazegepant for acute migraine
After a successful end-of-phase 2 meeting with the FDA, Biohaven Pharmaceuticals announced in a press release that intranasal vazegepant, a novel option for acute treatment of migraine, will soon be tested in a phase 3, double-blind, placebo-controlled trial.
“If approved, this novel intranasal formulation of vazegepant ... could add another innovative treatment option to help those suffering with migraine obtain rapid relief,” Vlad Coric, MD, CEO of Biohaven, said in the press release.
In the phase 2/3 dose-finding trial, intranasal vazegepant 10 mg and 20 mg was found to be statistically superior to placebo in providing freedom from pain and other bothersome symptoms at 2 hours, with rapid onset of pain relief at 15 minutes and sustained benefits over 48 hours. The phase 3 trial will further evaluate the 10 mg dose of the drug.
Vazegepant is delivered to the nasal cavity using the Unidose System (Aptar Pharma), an FDA-approved device designed for systemic delivery of drugs. According to the release, vazegepant could also be combined with Nurtec ODT (rimegepant, Biohaven), a calcitonin gene-related peptide-targeting drug for acute migraine in a fast-acting orally disintegrating tablet.
“Patients with migraine deserve multiple therapeutic options to better treat their migraines and return to their daily lives,” Robert Croop, MD, chief development officer of neurology for Biohaven, said in the press release.
Disclosures: Coric and Croop are employees of Biohaven Pharmaceuticals.