Biohaven Pharmaceuticals will seek FDA approval of a new fast-acting nasal spray for migraine, after the drug soared through a Phase 3 clinical trial.
The drug, zavegepant, is a follow-up to Biohaven’s migraine pill Nurtec ODT, which won FDA approval in 2020. Like Nurtec, it’s part of a new class of migraine treatments that target the brain chemical CGRP (calcitonin gene-related peptide).
If approved, zavegepant would become the first CGRP nasal spray for acute migraine treatment on the market.
Patients given the drug experienced statistically significant pain relief within 15 minutes and returned to normal functioning within half an hour, according to data Biohaven released Monday morning.
The drug also met its secondary goal of freedom from pain and “most bothersome symptom” (such as nausea) after two hours, and outperformed a placebo on 15 different outcome measures, the company said. The trial enrolled 1,400 patients with at least a one-year history with migraine.
“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,” CEO Vlad Coric said in a statement.
With the new drug, Biohaven aims to give patients “another important tool to combat migraine,” Coric added. The company is hoping the formulation will appeal not only to those who want faster pain relief, but also to patients who experience side effects like nausea when taking pills.
Biohaven said it expects to file a New Drug Application for intranasal zavegepant with the U.S. Food and Drug Administration during the first quarter of 2022. The company is also working on a capsule version.
Biohaven’s first migraine drug, Nurtec ODT (orally disintegrating tablet) has been surpassing sales expectations since winning a second FDA approval for prevention of episodic migraine last spring.
Last month, the company struck a deal potentially worth $1.24 billion with pharma giant Pfizer to commercialize Nurtec outside the U.S.
Contact Natalie Missakian at news@newhavenbiz.com.
