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From Earlier: Forest Laboratories and Gedeon Richter Announce Positive Phase III Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder


Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. today announced preliminary top-line results from a Phase III clinical trial of cariprazine, an investigational antipsychotic agent, in patients with acute mania associated with bipolar I disorder.

For the primary endpoint, the Young Mania Rating Scale, 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.

Posted-In: News FDA


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