Biohaven Pharmaceutical has reported positive findings from the Phase II/III clinical trial that assessed vazegepant for the acute treatment of migraine.
Vazegepant is a calcitonin gene-related peptide (CGRP) antagonist designed for intranasal administration. The Phase II/III trial evaluated a 5mg, 10mg and 20mg dose of the drug in a total of 1,673 patients.
The two higher doses showed statistical superiority over placebo on the co-primary endpoints of pain reduction and freedom from most bothersome symptom at two hours after a single dose.
Biohaven added that the benefits sustained for 48 hours without the need for rescue medication.
In addition, vazegepant was found to be superior on various secondary endpoints and demonstrated early activity.
The drug showed rapid onset with pain relief at 15 minutes with the 10mg and 20mg doses, and return to normal function by 30 minutes with the 20mg dose. These effects sustained at two hours.
Intranasal vazegepant was well tolerated, with adverse events inculding dysgeusia and nasal discomfort. The company said that most of the adverse events were mild in intensity.
Additional data from the trial will be reported at scientific meetings next year.
Biohaven Pharmaceutical CEO Vlad Coric said: “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 II/III dose-finding trial, may allow us to accelerate this program with only one additional positive efficacy trial likely needed for submission.”
The company is also developing rimegepant for the prevention of migraine. The drug is currently under review by the US regulatory agency.
Biohaven expects intranasal vazegepant to complement its CGRP targeting agents, including rimegepant.