Biohaven Pharmaceuticals’ drug for obsessive compulsive disorder fell short of the desired outcome in a recent study, but the company says it still plans to advance it to the final stage of human testing.
Biohaven said the Phase 3 trial would include a larger sample size and higher dose of the drug, troriluzole, which regulates the brain chemical glutamate.Â
The New Haven company said patients who had an inadequate response to standard treatment showed “consistent numerical improvement” over a placebo when taking 200 mgs. of troriluzole daily. But the improvement at week 12 was not statistically significant, the company reported.
Biohaven said its main priority has been its recently approved migraine drug Nurtec ODT. But it has been testing troriluzole’s effectiveness against several diseases, including OCD, Alzheimer’s and spinocerebellar ataxia.
It discontinued plans to pursue the drug as a treatment for generalized anxiety disorder in February following disappointing results in a clinical trial.
“Our strategy is to only further invest in troriluzole indications where we find an emerging drug signal,” CEO Vlad Coric, MD, said in a statement. “We are pleased to report these OCD study results that show a consistent and clinically meaningful drug effect at all study timepoints in patients who had an inadequate response to existing standard of care treatments.”Â
“This study provides our R&D team with the necessary data to refine and adequately power subsequent trials to advance troriluzole in OCD,” he added. “Based upon these results, we will have an End of Phase 2 meeting with the FDA and plan to initiate an appropriately powered pivotal Phase 3 study of two doses of troriluzole versus placebo.”
