Gedeon Richter and Forest Labs' cariprazine Phase III trials on schizophrenia meet primary endpoint

Feb 28 2012

Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. today announced positive top-line results in 2 Phase III clinical trials of cariprazine (RGH-188) for the treatment of acute exacerbation of schizophrenia.

For the primary endpoint in each study, the Positive And Negative Syndrome Scale (PANSS), the data showed that cariprazine-treated patients experienced significant symptom improvement compared to placebo-treated patients. All doses showed statistically significant separation from placebo starting at week 2 and at each subsequent time point with the higher dose showing separation as early as week 1 of treatment. Further analyses of the data in each study will be completed in the coming weeks. The results of these 2 studies were consistent with the results of the previously completed placebo-controlled Phase IIb fixed-dose study in this population.

Cariprazine is also currently being investigated in clinical studies for patients with bipolar depression, and as an adjunct treatment for Major Depressive Disorder (MDD). Recently, results were disclosed for a third positive trial in bipolar mania.

"By successfully meeting the primary endpoint in each of these studies, we now have 3 positive schizophrenia trials and 3 positive bipolar mania trials," said Dr. Marco Taglietti, President of Forest Research Institute. "We look forward to filing the NDA for both indications in 2012."

"We are pleased with these results which demonstrate that cariprazine provided significant improvement in symptoms for patients suffering from schizophrenia," said Dr. Zsolt Szombathelyi, Research Director of Gedeon Richter Plc. "It is indeed very encouraging that following successful Phase III trials in bipolar mania and positive Phase III trials in schizophrenia, we may offer promising treatment options for both conditions."