Biohaven Pharmaceuticals’ China subsidiary BioShin has taken a key step forward in its plan to win approval to sell the New Haven biotech’s new migraine drug in the Asia-Pacific region.
BioShin said it has enrolled the first patients in a Phase 3 clinical trial of the drug, known generically as rimegepant, being conducted in China and South Korea.
The double-blind, randomized trial is evaluating the safety and efficacy of the drug for the acute treatment of migraine.
Biohaven launched the drug under the brand name Nurtec ODT in March after winning U.S. Food & Drug Administration approval last February.
“We believe that rimegepant will meet the unmet medical needs of migraine patients in the Asia-Pacific region, as it is doing in the USA,” said BioShin CEO Dr. Karl Lintel.
The drug is one of a new class of migraine treatments known as CGRP (calcitonin gene-related peptide) receptor antagonists. It works by blocking a brain chemical that plays a role in the disease.
There are now several injectable CGRP migraine drugs on the market, but Nurtec was only the second orally-administered version to win FDA approval.
Biohaven’s drug is unique in that it can dissolve quickly in the mouth, and provides quick onset and long-lasting pain relief, the company says.
The Asian trial comes after BioShin closed on a $60 million Series A funding round in September.
Contact Natalie Missakian at news@newhavenbiz.com
