Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc today announced positive top-line results from a Phase IIb clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of acute exacerbation of schizophrenia.
For the primary endpoint, the Positive and Negative Syndrome Scale (PANSS), the data showed that patients with schizophrenia treated with cariprazine experienced significant symptom improvement compared to placebo patients within the first week of treatment and at each subsequent time point studied.
Based on this latest schizophrenia data, subject to a complete review of the full results, and the previously announced Phase II results in patients suffering from acute mania associated with bipolar I disorder, the companies intend to initiate Phase 3 trials for both indications in early 2010. Cariprazine is currently also undergoing Phase II clinical trials in patients with Bipolar Depressive Disorder and as adjunctive therapy in Major Depressive Disorder.
Discovered by researchers at Gedeon Richter and licensed in the United States and Canada by Forest Laboratories in 2004, cariprazine is an orally active D3/D2 partial agonist with preferential binding to D3 receptors. Additionally, cariprazine has a relatively low potency at other receptor sites, such as 5-HT2C, histamine H1, muscarinic, and adrenergic receptor sites, that have been associated with adverse events in some other drugs in the class.