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Lurasidone NDA Accepted for Review

The FDA has accepted for review Dainippon Sumitomo Pharma America’s lurasidone NDA for the treatment of acute schizophrenia.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has accepted for review Dainippon Sumitomo Pharma America’s lurasidone NDA for the treatment of acute schizophrenia. The NDA was submitted on December 30, 2009 and will receive a standard review.

“We are pleased that the lurasidone NDA has been accepted for review by the FDA,” said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. “We look forward to the potential lurasidone may bring as it represents our commitment to developing therapies that provide clear value to patients and health care professionals.”

The NDA includes data from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients with schizophrenia. Results show that lurasidone demonstrated significantly greater improvement versus placebo on the primary efficacy measure at study endpoint. Additionally, the compound was well tolerated and associated with limited weight gain or changes in metabolic parameters.

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