Dainippon Sumitomo Lurasidone NDA Accepted for Review

Dainippon Sumitomo Pharma America, Inc.’s NDA for lurasidone for the treatment of acute schizophrenia has been accepted for review by the FDA. 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. The efficacy and safety of lurasidone were evaluated in five six-week, placebo-controlled studies in hospitalized patients with schizophrenia. In four of these studies, lurasidone demonstrated significantly greater improvement versus placebo at study endpoint. In all five studies, lurasidone was well-tolerated and associated with limited weight gain or changes in metabolic parameters.