Forest Laboratories and Gedeon Richter have announced preliminary top-line results from a Phase III clinical trial of cariprazine (RGH-188), an investigational antipsychotic agent, in patients with acute mania associated with bipolar I disorder.
For the primary endpoint, the Young Mania Rating Scale (YMRS), the data showed that cariprazine treated patients with acute manic episodes experienced significant improvements in symptoms compared to placebo-treated patients observed as early as day five of treatment and at each subsequent time point studied.
The results of this study were consistent with the results observed in the two previously completed pivotal placebo-controlled cariprazine studies in this patient population. Further analyses of the data will be completed in the coming weeks. Cariprazine is also currently being investigated in clinical studies for patients with schizophrenia, bipolar depression, and as an adjunct treatment for Major Depressive Disorder.
"As we continue to move forward with the development of this important compound, these positive phase III results further demonstrate the opportunity for cariprazine as a potential new treatment option for patients suffering from bipolar mania" said Marco Taglietti, MD, Senior Vice President of Research and Development and President, Forest Research Institute.
"In the three consecutive positive trials, statistically significant results demonstrated improvement in symptoms compared to placebo, importantly including the low dose range arm. We consider today's results a major milestone achieved on the long road towards bringing such a promising product to the market," commented Zsolt Szombathelyi, MD, Research Director of Gedeon Richter Plc.