The company said the study demonstrated broad efficacy, showing statistically significant superiority to placebo over a total of 15 prespecified primary and secondary outcome measures.
On Monday, Biohaven Pharmaceutical announced topline results from the second pivotal study of intranasal zavegepant for the treatment of acute migraine in adults.
The Phase III study, which randomized 1,405 adults with at least a one-year history of migraine, showed treatment with 10 mg of intranasal zavegepant reached the regulatory endpoints of pain freedom and freedom from most bothersome symptom at 2 hours. The company said the study demonstrated broad efficacy, showing statistically significant superiority to placebo over a total of 15 prespecified primary and secondary outcome measures.
“Patients with migraine rate speed of onset as one of the most important aspects of an effective therapy. The data from this trial shows that intranasal zavegepant delivered impressive performance on this metric by demonstrating statistically significant pain relief within 15 minutes and return to normal function within 30 minutes,” said Dr. Richard B. Lipton, M.D., professor and vice chair of neurology at the Albert Einstein College of Medicine and director of the Montefiore Headache Center. “Additionally, non-oral treatments offer additional benefits for patients who experience nausea, vomiting or gastroparesis (with slow absorption). Intranasal zavegepant will be an important new treatment option for patients who require a rapid and non-oral option for acute treatment of their migraine attacks.”
Biohaven CEO Dr. Vlad Coric, M.D. said that Intranasal zavegepant was designed to provide effective, ultra-rapid treatment for acute migraine.
“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,” Coric stated.
With these results, along with a previous Phase II/III trial which met the primary safety and efficacy objectives, Biohaven said it is moving forward with plans for regulatory submissions in the U.S. and other countries. The company intends to submit a New Drug Application for zavegepant with the U.S. Food and Drug Administration in Q1 2022, and with other countries at a later date.
Zavegepant is the only CGRP receptor antagonist in late-stage development with both intranasal and oral formulations. If it is approved, the drug would be positioned as the first intranasal calcitonin gene-related peptide (CGRP) receptor antagonist for the acute treatment of migraine. This is the company’s second clinical candidate. Biohaven’s first drug, Nurtec ODT (rimegepant), was approved by the FDA in May for the treatment of migraine and prevention of episodic migraine.
