(RTTNews) - Wednesday, Forest Laboratories, Inc. (FRX) and Gedeon Richter Plc said that data from a Phase IIb clinical trial of the investigational antipsychotic agent Cariprazine to treat acute schizophrenia showed positive results.

For the primary endpoint, which is the Positive and Negative Syndrome Scale or PANSS, the data showed that schizophrenia patients treated with the drug experienced significant symptom improvement, compared with patients on placebo, within the first week of treatment and at each subsequent time point studied.

“Both the latest clinical trial results for cariprazine in patients suffering from schizophrenia and the previous proof of concept results in bipolar mania, confirm our long held belief in this compound,” said Howard Solomon, chairman and chief executive officer of Forest Laboratories.

The placebo- and active-controlled, fixed dose study enrolled patients with acute exacerbation of schizophrenia. Patients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for schizophrenia and had a PANSS total score between 80 and 120 were eligible for enrollment into the study.

Based on the Phase 2b data, after a complete review of the full results, and the previously announced Phase 2 results in patients with acute mania associated with bipolar I disorder, the companies intend to initiate Phase 3 trials for both indications in early 2010. The drug is also currently undergoing Phase 2 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, the drug 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.

FRX is closed Wednesday’s last trade on the New York Stock Exchange at $27.29, down $0.59 or 2.12%.

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