Allergan and Hungarian pharmaceutical firm Gedeon Richter have reported positive top-line data from a Phase III clinical trial of cariprazine (Vraylar) in adults suffering from major depressive episodes due to bipolar I disorder.
Vraylar is an oral, daily atypical antipsychotic indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Both 1.5mg and 3mg doses of cariprazine have met the trial’s primary endpoint with a significant improvement on the Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week six when compared to placebo.
Cariprazine was found to be generally well-tolerated, with sedation, somnolence, dizziness, akathisia, and nausea being the most common adverse events.
Allergan chief research and development officer David Nicholson said: “Phase III data provides further support for cariprazine as a potential treatment for adults with bipolar depression, and adds to the growing clinical profile of this compound in mental health disorders.
“At Allergan, we're committed to supporting underserved populations with limited treatment options, and look forward to submitting a supplemental new drug application (sNDA) for cariprazine as a treatment option for patients suffering from bipolar I depression.”
The firm intends to submit the sNDA to the US Food and Drug Administration (FDA) in the second half of next year.
Performed in 488 subjects, the randomised, double-blind, placebo-controlled, parallel-group, multicentre, fixed-dose Phase III trial investigated the efficacy, safety, and tolerability of cariprazine.
The trial included a treatment period of six weeks and a one week safety follow-up period without the investigational product.