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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Seeks More Data on Forest & Gedeon Richter’s Schizophrenia Drug

Nov. 22, 2013

The FDA has handed Forest Laboratories and Gedeon Richter a complete response letter asking for more data on cariprazine, the companies’ drug candidate to treat schizophrenia and manic or mixed episodes of bipolar I disorder in adults.

The agency affirmed the drug’s efficacy in the treatment of schizophrenia and mania, but “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,” said Marco Taglietti, president of Forest Research Institute, Thursday.

Cariprazine has been evaluated for the proposed indication in a clinical program involving more than 2,700 patients. The drug, an orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist, is also under development as an adjunct treatment for major depressive disorder.

Forest plans to meet with the FDA to discuss the complete response letter and determine exactly what additional information and clinical data the agency is looking for. — Lena Freund

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