Biohaven enrolls 880 patients testing troriluzole in generalized anxiety disorder

Biohaven Pharmaceutical has enrolled over 880 patients in less than nine months, in its pivotal Phase 3 clinical trial of troriluzole in generalized anxiety disorder (GAD).

GAD is a chronic and long-lasting disorder in which a person has uncontrollable, excessive anxiety and worry and is often associated with significant functional impairment. According to the Anxiety and Depression Association of America (ADAA), millions of Americans suffer from GAD, Biohaven noted.

Furthermore, if not appropriately treated, GAD has a chronic course associated with significant disability and high public burden. The current standard of care includes psychotherapy and medications including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine inhibitors (SNRIs) and benzodiazepines. It is estimated that only approximately 30% of GAD sufferers fully respond to SSRI/SNRIs and the use of benzodiazepines can be associated with abuse, dependence and withdrawal symptoms, Biohaven noted.

Vlad Coric, CEO of Biohaven said that GAD is one of the most prevalent anxiety disorders seen in both primary care and specialist settings. He hopes that this Phase 3 study will demonstrate troriluzole’s novel mechanism of action as a potential approach for addressing the debilitating consequences of GAD without the limitations associated with current treatments.

Loren Aguiar, Vice President, Research and Development at Biohaven said that the patients and clinical trial sites helped complete enrollment in this trial of troriluzole in less than nine months.  “The brisk study enrollment reflects the large numbers of patients who are not satisfied with their response on current therapies. We believe that troriluzole could be a promising alternative to current standards of care and look forward to topline results in the near term,” Aguiar said.