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.

“Phase III data provides further support for cariprazine as a potential treatment for adults with bipolar depression.”

“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.”

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By GlobalData

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.