DSPA submits lurasidone NDA to the FDA

Jan 4 2010

Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lurasidone, an investigational atypical antipsychotic agent for the treatment of schizophrenia. The application, submitted on December 30, 2009, includes data from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients.

"This NDA marks a significant milestone for our company as we accelerated the global clinical development of lurasidone and achieved an earlier than anticipated submission to the FDA," said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. "We believe lurasidone will be a valuable new option for patients, their families and physicians for the treatment of schizophrenia."

The efficacy of once-daily lurasidone was demonstrated in four six-week, placebo-controlled studies, involving hospitalized patients with schizophrenia. These studies included the global PEARL 1 and PEARL 2 clinical trials (Program to Evaluate the Antipsychotic Response to Lurasidone). Clinical trials demonstrated that lurasidone was generally well-tolerated with limited weight gain or changes in metabolic parameters. Furthermore, lurasidone was associated with mild changes in movement disorder parameters and prolactin levels.

"Lurasidone may offer physicians a new, once-daily treatment option for schizophrenia, where many unmet needs remain," said Antony Loebel, M.D., vice president of clinical development, DSPA. "We believe lurasidone has the potential to treat the symptoms of schizophrenia, while limiting troublesome side effects, such as weight gain and related metabolic risks."