Biohaven Pharmaceutical is eyeing filing for approval early next year for its experimental pain spray after new data showed it hit its primary endpoints in a phase 3 test.
The drug, the small-molecule CGRP receptor known as zavegepant that can work as a spray and an oral med, showed “ultra-rapid pain relief” at the earliest measured time point of 15 minutes and sustained efficacy through 48 hours after a single intranasal dose in acute migraine, according to Biohaven.
It hit its co-primary endpoints—namely pain freedom and freedom from “most bothersome” symptoms at two hours—and showed “broad efficacy” after showing statistically significant superiority to placebo across a total of 15 prespecified primary and secondary outcome measures.
The nearly 1,500-patient strong study found the drug was generally clean on safety, with the majority of adverse events mild in intensity.
Full data are yet to be shared, but the New Haven, Connecticut-based pharma is rushing to the FDA with these latest data, hoping to file for approval in the first quarter of 2021. It will hope to nab another FDA migraine approval after getting a recent green light for Nurtec for acute migraine—as well as for preventing the disorder—earlier in the year,
It also has a big migraine market ahead of it, with rivals Amgen, Teva and Eli Lilly working overtime for a disorder that affects around 40 million people in the U.S., though Biohaven will hope a spray version may prove more attractive to many sufferers.
This is also a much needed R&D win for the company, which saw flops for Alzheimer’s disease and multiple system atrophy this year as well as obsessive compulsive disorder last year.
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“Intranasal zavegepant was designed to provide ultra-rapid pain relief and expand our CGRP receptor-antagonist franchise by providing patients with another important tool to combat migraine,” said CEO Vlad Coric, M.D.
“The trial results clearly show that the performance of this formulation exceeded expectations by demonstrating superiority over placebo on pain relief at 15 minutes and return to normal function by 30 minutes. The impressive efficacy, safety and tolerability profile shown in this trial highlights the potential of zavegepant to usher in a new era of non-oral CGRP targeting migraine therapies that may transcend the traditional boundaries of older legacy intranasal migraine approaches.”
Alongside the data, the company announced Coric will also take on the chairman of the board position, and it hired a new chief financial officer in Matthew Buten, who comes from Foresite Capital.
This comes after former chair of Declan Doogan, M.D., and CFO James Engelhart announced they were retiring from their positions.
Biohaven shares were flat on the news early Monday morning.