Not hitting the primary endpoint of a phase III study caused the U.S. FDA to say it would not review Biohaven Ltd.’s NDA for troriluzole to treat spinocerebellar ataxia (SCA), an ultra-rare disorder.
While Biohaven Pharmaceutical Holding Co. Ltd.’s phase II/III proof-of-concept study of troriluzole for treating obsessive-compulsive disorder (OCD) failed to meet its primary outcome measure at week 12, the company found enough silver in the study’s lining to press on for a larger phase III trial.
Top-line results from Biohaven Pharmaceutical Holding Co.’s phase III trial of troriluzole against placebo in treating generalized anxiety disorder (GAD) failed to hit its primary endpoint, prompting the company CEO to say the poor results support halting development plans for the glutamate modulator as a monotherapy in GAD.