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Trials & Filings

Forest, Richter Schizophrenia Drug Gets CRL

Agency wants trial data

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Forest Laboratories and Gedeon Richter Plc. received a Complete Response Letter (CRL) from the FDA regarding the 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 CRL, the FDA acknowledged that cariprazine demonstrated effectiveness in the treatment of schizophrenia and mania associated with bipolar disorder, but declared that more information, including additional clinical trial data, would be needed. A spokesperson for Gedeon Richter indicated that this may not require conducting further trials, but could not be sure of this until after the companies consult with FDA.

“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 Dr. Marco Taglietti, president, Forest Research Institute. The companies plan to meet with the FDA to discuss the CRL and figure out their next step.

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