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FDA turns down Forest/Gedeon Richter’s antipsychotic

US regulator wants more information for cariprazine
FDA headquarters White Oak

There was disappointment today for Gedeon Richter and its marketing partner Forest Laboratories after US regulators declined to approve their new antipsychotic cariprazine.

The Food and Drug Administration (FDA) explained in a complete response letter to the companies that more information, including clinical trial data, was needed before it could approve the drug for schizophrenia and the acute treatment of mania associated with bipolar I disorder in adults.

This is despite the FDA acknowledging that cariprazine had demonstrated some effectiveness in treating these psychotic disorders.

Dr Marco Taglietti, president of the Forest Research Institute, was pragmatic in his response to the agency's request.

He said: “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 minimising the potential for the development of adverse events generally associated with this class of drug.”

If so, the future of cariprazine in the US is far from over, and Dr Taglietti confirmed that both Forest and Gedeon Richter intend to meet with the FDA to discuss plans for the medicine.

“We are committed to pursuing novel treatment options like cariprazine to address patient needs,” he added.

Cariprazine was originally developed by Gedeon Richter and is an antagonist of the dopamine D3, D2 and serotonin 2B receptors, which play a part in the development of psychiatric conditions.

Forest later licensed rights to market the drug in the US and Canada, submitting the FDA new drug application in late 2012.

The company's former CEO Howard Solomon has previously named cariprazine as a major product for Forest as it looks to return to growth, making FDA approval all the more crucial.

Article by
Phil Taylor

21st November 2013

From: Sales

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