Clinical Trial Begins for Third-Generation CGRP-Antagonist Nasal Spray for Acute Migraine Treatment

The first patient has been enrolled in a phase 2/3, double-blind, placebo-controlled trial of intranasally administered BHV-3500 (Biohaven Pharmaceutical, New Haven, CT) being studied for acute treatment of migraine. 

In this trial, 3 doses of BHV-3500 (5mg, 10mg, and 20mg) will be compared to treatment with placebo for acute relief during migraine attack. With a planned enrollment of 400 randomized subjects per treatment arm, the trial aims to prove efficacy at 2 hours postdose on the endpoints of freedom from pain and the most bothersome migraine-associated symptom. 

"This is the first late-stage clinical trial designed to assess the efficacy of an intranasally administered CGRP receptor antagonist in the acute treatment of migraine,” said Vlad Coric, MD, CEO of Biohaven. “The pharmacokinetic profile from our recently completed Phase 1 trial suggests the potential for an ultra-rapid onset of action without the need for an injection. … We believe that intranasal BHV-3500 may provide people with ultra-rapid onset of migraine relief in a form that can easily be self-administered whenever and wherever a migraine strikes."

A novel, structurally distinct, third-generation calcitonin gene-related peptide (CGRP) receptor antagonist, BHV-3500, has favorable potency and low protein binding. Its physicochemical properties make it potentially suitable for multiple routes of delivery, including nasal, inhalation, or oral administration. Initially, it is being developed as an intranasal formulation.