Forest Labs Gets Complete Response Letter For Cariprazine; Addl. Data Sought

(RTTNews) - Forest Laboratories Inc. (FRX) and Gedeon Richter Plc. announced Thursday that the U.S. Food and Drug Administration or FDA issued a complete response letter regarding the New Drug Application or NDA for cariprazine, an atypical antipsychotic for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

In the complete response letter, the FDA acknowledged that cariprazine clearly demonstrated effectiveness in the treatment of schizophrenia and mania associated with bipolar disorder. However, the Agency indicated more information, including additional clinical trial data, would be needed.

Forest Laboratories said that the company and Gedeon Richter plan to meet with the FDA in the very near future to discuss the complete response letter and define a path forward.

Cariprazine, an investigational drug, is an atypical antipsychotic for the treatment of patients with schizophrenia and for patients with manic or mixed episodes associated with bipolar I disorder. The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2,700 patients. Cariprazine is protected by a composition-of-matter patent that expires in 2027 without patent term extension.