Allergan Reports Results From MD-72 Adjunctive MDD Trial - Quick Facts

(RTTNews) - Allergan plc (AGN) and Gedeon Richter Plc said 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 the trial. The MD-72 trial was a 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 who failed to adequately respond to antidepressant monotherapy.

"We are disappointed with the results of this trial. However, we believe that our plan to move forward with another Phase 3 study in Adjunctive MDD coupled with our previous positive clinical trial would provide the two studies needed for submission," said David Nicholson, Chief R&D Officer at Allergan.

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.