More than 2,100 participants have been enrolled in the phase 2/3 clinical trial (NCT03872453) of vazegepant (BHV-3500; Biohaven Pharmaceutical, New Haven, CT) a nasally delivered calcitonin gene-related peptide (CGRP)-receptor antagonist for the acute treatment of migraine.
Vazegepant (formerly BHV-3500) is a highly potent, selective, and structurally unique small molecule with distinctive physicochemical properties that may allow multiple routes of delivery. Intranasal vazegepant is delivered nasally with a dosing system (Aptar Pharma Unidose System; AptarGroup, Crystal Lake, IL) that enables systemic delivery of drugs without the need for injection or administration by a healthcare provider.
The double-blind, placebo-controlled trial is designed to measure efficacy on regulatory endpoints for acute treatment of migraine—freedom from pain and the most bothersome migraine-associated symptom at 2 hours post-dose—across 3 doses of vazegepant (5 mg, 10 mg, and 20 mg) vs placebo.
The trial will also study other clinical outcomes that are very important to people living with migraine, such as pain relief and the return to normal functioning.
“Our phase 2/3 trial of vazegepant represents the first late-stage study of an intranasally delivered CGRP receptor antagonist, propelling us a step closer to providing patients with multiple, easy-to-use formulations to treat migraine,” said Elyse Stock, MD, CMO, Biohaven. “Vazegepant is complementary to our lead migraine asset, rimegepant, which has met primary efficacy endpoints in 3 completed phase 3 clinical trials and is currently under review with the FDA."
Robert Croop, MD, chief development officer—neurology, Biohaven, said, "We are excited to complete enrollment with vazegepant, our third-generation CGRP receptor antagonist, in this pivotal phase 2/3 trial with the goal of ultimately providing patients with important new treatment options that can easily be self-administered whenever and wherever a migraine strikes."
Karissa Gable, MD
Michael V. Robers, MD, Deepak Soneji, MD, PhD, and Lilyana Amezcua, MD, MS
Evanthia Bernitsas, MD