Biohaven looks to expand migraine treatments

NEW HAVEN — Biohaven Pharmaceuticals, which already has a migraine treatment drug on the market, is taking an important step toward bringing a second version of the product to consumers.

The New Haven-based biotechnology company is preparing to bring a nasally administered treatment for migraine headaches to the federal Food and Drug Administration for approval.

Biohaven Pharmaceuticals had its first migraine treatment, a pill form of its drug zavegepant, approved by the FDA in February 2020.

Biohaven reported the results of its Phase 3 testing for the nasal delivery version of zavegepant earlier this week. The study showed the drug demonstrated significant pain relief within 15 minutes and return to normal function within 30 minutes.

The significance of these latest findings is due to the fact that that some migraine patients may experience nausea associated with the oral version of the drug. The Phase 3 trial enrolled 1,400 patients with at least a oneyear history of migraine, and evaluated safety and effectiveness of a single dose of zavegepant compared to a placebo.

Dr. Vlad Coric, chief executive officer at Biohaven, said the company “is committed to delivering on its promise to provide new treatment options for the millions of people living with this debilitating disease.”

Based on the latest test results, Biohaven plans to file a new drug application for zavegepant with the FDA during the first quarter of next year, according to Coric. A decision by the FDA wouldn’t come until the end of 2022, he said.

Nearly 40 million people in the U.S. suffer from migraine, characterized by such symptoms as pulsating headaches that can be associated with nausea or vomiting, and/or sensitivity to sound or light. Coric said the nasal version of the drug offers a quicker treatment than the pill form.

“That return to normal functioning is so important,” he said. The pill form of the drug offered treatment of symptoms within 60 minutes, compared to 15 minutes with the nasal version of the drug, according to Coric.

“It gives you a level of flexibility,” he said. About one-half of all migraine sufferers can’t deal with the side effects associated with oral version of zavegepant, according to Coric.

“Migraine strikes in the prime of people’s lives,” he said. “It’s a big market and we’ve demonstrated our expertise in this area. We want to make sure we have solution for patients, wherever and whenever they need it.”