After meeting co-primary end points of pain freedom and freedom from the most bothersome symptom, the acute migraine agent has been cleared for a phase 3 trial by the FDA.
Vlad Coric, MD
Biohaven Pharmaceuticals has announced that data from a phase 2 trial of intranasal vazegepant in doses of 10- and 20-mg was statistically superior to placebo for both co-primary endpoints of pain freedom and freedom from the most bothersome symptom (MBS).
Based on end of phase 2 interactions with the FDA, the company added that it will ultimately advance to a phase 3 clinical trial with the lower dose. The FDA’s decision to give the go-ahead came after the drug achieved statistical superiority on the co-primary endpoints at 2 hours post-dose.
"We are pleased to successfully complete our end of Phase 2 meeting with the FDA so that we can continue to advance the development of intranasal vazegepant,” Robert Croop, MD, chief development officer of neurology, Biohaven, said in a statement. “Patients with migraine deserve multiple therapeutic options to better treat their migraines and return to their daily lives."
The therapy is the second member of Biohaven’s NOJECTION Migraine Platform—the first being rimegepant (Nurtec ODT)—to show success in a clinical trial. The company stated that it hopes vazegepant would be complementary to rimegepant and other calcitonin gene-related peptide (CGRP) agents.
Rimegepant orally disintegrating tablets 75 mg were approved by the FDA in February 2020 for the acute treatment of migraine with or without aura in adults, but were not indicated for the preventive treatment of migraine.
In the phase 2/3 clinical trial, Biohaven tested 5-mg, 10-mg, and 20-mg doses of vazegepant, but the therapy only showed statistical significance in the 2 higher doses. Patients who were given vazegepant 10 and 20 mg saw a 41.9% and 42.5% reduction of MBS compared to 33.7% in placebo. Additionally, the drug showed evidence of rapid onset with pain relief, as early as 15 minutes, as well as return to normal function at 30 minutes and sustained benefits through 48 hours.
Intranasal vazegepant is a small molecule CGRP-targeting antagonist that is administered using the Aptar Pharma Unidose System (UDS), which was approved in July 2019 and was designed to enable systemic delivery of drugs.
“If approved, this novel intranasal formulation of vazegepant will complement our recently approved, Nurtec ODT (rimegepant) orally disintegrating tablet, currently marketed for acute treatment of migraine and could add another innovative treatment option to help those suffering with migraine obtain rapid relief," Vlad Coric, MD, chief executive officer, Biohaven, said in a statement. Coric added that if the planned phase 3 trial shows positive results, the company would potentially file a new drug application sometime in the next year.
Biohaven to advance vazegepant into phase 3 for the acute treatment of migraine following successful end of phase 2 meeting with FDA [news release]. New Haven, Connecticut: Biohaven Pharmaceuticals. March 23, 2020. Accessed March 23, 2020. prnewswire.com/news-releases/biohaven-to-advance-vazegepant-into-phase-3-for-the-acute-treatment-of-migraine-following-successful-end-of-phase-2-meeting-with-fda-301027933.html