Biohaven Pharmaceutical has announced that a Phase 2/3 trial of its intranasal vazegepant (BHV-3500) demonstrated that 10 and 20 mg doses of the intranasal migraine therapy were more effective than placebo for pain relief and that the drug was well tolerated with no indication of liver toxicity. Biohaven announced the initiation of the study in April 2019.
The dose ranging study, which enrolled 1,673 migraine patients, compared 5, 10, and 20 mg of vazegepant delivered via Aptar’s Unit Dose System (UDS) to placebo. The 10 and 20 mg doses were statistically superior to placebo for both freedom from pain and freedom from symptoms such as nausea and light sensitivity at 2 hours post dose. Patients using vazegepant experienced pain relief as soon as 15 minutes post dose and stayed free from pain for 48 hours.
Biohaven CEO Vlad Coric commented, “We are excited to demonstrate the efficacy and tolerability of the first intranasal CGRP receptor antagonist for patients with migraine. These positive results, in a large, multiple arm phase 2/3 dose finding trial, may allow us to accelerate this program with only one additional positive efficacy trial likely needed for submission. Â Biohaven is grateful to the patients and investigators who have contributed to the success of the vazegepant and rimegepant programs.”
Read the Biohaven press release.
