Forest Laboratories, Richter report positive results from cariprazine Phase IIb trial for bipolar depression

Forest Laboratories, Inc. (NYSE:FRX) and Gedeon Richter Plc. today announced positive topline results from a Phase IIb trial evaluating the efficacy and safety of the investigational antipsychotic cariprazine in patients with bipolar depression.

The trial consisted of four treatment groups: cariprazine 0.75 mg/day, 1.5 mg/day, 3.0 mg/day, and placebo. Statistically significant improvements were observed in the cariprazine 1.5 mg/day group relative to placebo at 6 weeks for the primary endpoint, the Montgomery-Asberg Depression Rating Scale (MADRS) total score and the key secondary endpoint, the Clinical Global Impressions - Severity (CGI-S) score.

"We are pleased with the positive results of this study. In addition to previously completed Phase III trials in schizophrenia and bipolar mania, we now have positive Phase IIb studies for cariprazine in both bipolar depression and major depressive disorder. Our goal is to continue developing cariprazine for patients with a broad range of psychiatric conditions," said Marco Taglietti, M.D., Executive Vice President of Drug Development and Research at Forest Laboratories, Inc.

"Cariprazine is a critical element to Richter's discovery platform," explained Dr. Zsolt Szombathelyi, Research Director of Gedeon Richter Plc. "We are pleased with the topline results of the Phase IIb trial and are committed to developing an important new treatment option for patients suffering from bipolar depression."