A potential treatment for obsessive compulsive disorder being developed by Biohaven Pharmaceuticals missed the mark in a clinical trial last year, but officials are hoping it will perform better in a new trial that has just enrolled its first patient.
The New Haven company, maker of the new migraine pill Nurtec ODT, said it has begun enrolling an expected 600 patients in a Phase 3 study to test the efficacy and safety of its glutamate-regulating drug troriluzole.
Glutamate is a brain chemical which is believed to play a role in numerous neurological and psychiatric disorders.
In a smaller proof-of-concept trial last year, OCD patients who failed standard treatments showed improvement while taking the Biohaven drug, but the results were not considered statistically significant.
Still, Biohaven said at the time that there was enough of a clinically meaningful effect to continue pursuing the program. Company officials are hoping a larger sample size and higher dose will produce better results.
Dr. Loren Aguiar, Biohaven’s vice president for research and development, said in a statement that the earlier study provided “valuable data for us to adequately power and design the Phase 3 studies.”
Patients will be given 280 mgs of the drug once a day in two double-blind, placebo controlled trials with identical study designs, Biohaven said. The trial will take place at sites in both the United States and Europe.
“We are excited to begin these new studies as approximately one-third of patients with OCD do not respond to currently available medications and new therapies are urgently needed,” she said.
More than 2 million people in the U.S. suffer from the disorder, which is marked by uncontrollable, recurring thoughts and behaviors.
Contact Natalie Missakian at news@newhavenbiz.com
