Allergan, Richter’s bipolar depression drug meets primary end point in phase 3 study

Vraylar (cariprazine) is an oral and once daily atypical antipsychotic secured approval for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder.

Gedeon Richter discovered and co-developed Vraylar, while Allergan secured license for the drug in the US and Canada.

The primary endpoint was met in the phase 3 study assessing patients with acute bipolar I depression treated with cariprazine 1.5 mg and 3 mg versus placebo.

Both groups demonstrated an improvement compared against placebo for the change from baseline to week six on the Montgomery-Asberg Depression Rating Scale (MADRS) total score, said Allergan.

Based on the results, Allergan intends to file a supplemental new drug application (sNDA) to the US Food and Drug Administration in the second half of 2018.

RGH-MD-54 is a phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter and fixed-dose clinical study in patients with bipolar I depression.

The study has randomized 488 patients to assess the efficacy, safety, and tolerability of cariprazine 1.5 mg/day and 3.0 mg/day compared against placebo in patients with bipolar I depression.

Allergan chief research and development officer David Nicholson said: "These phase 3 data provide 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.”

Gedeon Richter research director István Greiner said: "We consider today's positive results a major milestone in the process of making this promising treatment option available for patients suffering from bipolar depression and also widening the therapeutic scope of cariprazine.”