Cariprazine fails in Phase III trial for depression. -Allergan + Gedeon Richter

The MD-72 trial was a prospective, randomized, double-blind, placebo-controlled, parallel-group study evaluating flexible doses of cariprazine (1.5- 4.5 mg) as an adjunctive treatment to antidepressant therapy in adults with major depressive disorder (MDD) who failed to adequately respond to antidepressant monotherapy. The study was conducted at multiple centers, all within the United States .

Topline results from the MD-72 trial indicate that flexible doses of cariprazine did not separate significantly from placebo as an add-on treatment in this trial. In a previously conducted trial (MD-75), flexible doses of cariprazine (2-4 mg) were significantly more effective than placebo as an adjunctive treatment to antidepressant therapy in adults with major depressive disorder (MDD) who failed to adequately respond to antidepressant monotherapy. It is not uncommon that clinical trials in MDD fail to show a separation from placebo even with effective drugs. Both companies remain committed to developing cariprazine as a potential treatment option for patients suffering from this serious illness and will continue to work on a subsequent Phase III trial. Allergan and Gedeon Richter believe that their plan to move forward with another Phase III study in Adjunctive MDD coupled with previous positive clinical trial would provide the two studies needed for submission. This is an important next step to further develop the cariprazine program.

Cariprazine was approved by the FDA in September 2015 and is marketed as Vraylar in the US for the treatment of manic or mixed episodes of Bipolar I Disorder and Schizophrenia in adults.