FDA issues Complete Response Letter for cariprazine (Forest/Gedeon Richter) for Schizophrenia

Forest Laboratories, Inc. and Gedeon Richter Plc. announced that the FDA has issued a Complete Response Letter regarding the New Drug Application (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. Given the complex pharmacokinetics and metabolism of cariprazine, the FDA believes this request was made to better define the optimal dosing regimen to maintain the demonstrated efficacy, while minimizing the potential for the development of adverse events generally associated with this class of drug.