FDA calls for more info from Forest and Gedeon Richter on cariprazine

The US Food and Drug Administration has issued a complete response letter regarding the New Drug Application for cariprazine, submitted by USA-based Forest Laboratories (NYSEL FRX) and Hungary’s largest drugmaker Gedeon Richter (RICHT: HB).

In the complete response letter, the FDA acknowledged that 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, 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, we believe 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,” said Marco Taglietti, president, Forest Research Institute.