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May 24, 2022 BIOSCIENCE

FDA to review Biohaven’s nasal migraine drug; new drug falls short

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By Liese Klein

New Haven-based Biohaven announced on Monday that the FDA will review its zavegepant nasal spray for the acute treatment of migraine in adults.

A CGRP receptor antagonist, zavegepant provides migraine pain relief in as little as 15 minutes that lasts 48 hours after a single dose, according to the company. 

CEO Dr. Vlad Coric said, “If approved, zavegepant would provide a new treatment option for patients who need ultra-rapid relief, in as early as 15 minutes, and for those that experience nausea or vomiting and need a non-oral treatment option.”

The drug showed positive results in two trials submitted as part of the company’s new drug application to the FDA.

Zavegepant is one of a range of CGRP receptor antagonist migraine drugs acquired by Pfizer as part of its $11.6 billion purchase of Biohaven announced earlier this month. The drugs include Nurtec ODT, known as Vydura in the European Union. 

Pipeline drug falls short in trial 

Also on Monday, Biohaven reported disappointing results in a Phase 3 clinical trial of its drug troriluzole in patients with spinocerebellar ataxia (SCA), a genetic disorder that affects gait and coordination.

The drug's impact "did not reach statistical significance in the overall SCA population as there was less than expected disease progression over the course of the study," Biohaven said in a statement. 

One subset of patients did show benefits from treatment with troriluzole, and some experts cited said development of the drug should continue considering the lack of options for patients with the degenerative ailment.  

Dr. Susan Perlman, director of Ataxia Clinic and neurogenetics clinical trials at the David Geffen School of Medicine at UCLA said, “Given the excellent safety profile of troriluzole, and the fact that there are no approved treatment options for patients with this devastating neurodegenerative disorder, I am thrilled for my patients that Biohaven is planning to engage with the FDA to potentially move this program forward."

Contact Liese Klein at lklein@newhavenbiz.com.

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