FORT LEE, N.J., Jan. 4 /PRNewswire/ -- 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.
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.
About Lurasidone
Lurasidone is an atypical antipsychotic with a unique chemical structure that was discovered and developed by DSP. Lurasidone has high affinities for dopamine D(2), serotonin 5-HT(7), 5-HT(2A), 5-HT(1A), and noradrenaline alpha(2C) receptors and minimal-to-no affinity for histamine H(1) or cholinergic M(1) receptors.
About Dainippon Sumitomo Pharma America
Dainippon Sumitomo Pharma America, Inc. located in Fort Lee, N.J., is a subsidiary of Dainippon Sumitomo Pharma Co., Ltd. DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with more than 7,000 employees worldwide. DSP has a diverse portfolio of pharmaceutical, animal health and food and specialty products and strong research and development presence in the areas of CNS, diabetes, cardiovascular disease, and inflammation/allergy. In October 2009, Sepracor Inc., based in Marlborough, MA, became a subsidiary of DSP.
Dainippon Sumitomo Pharma America, Inc.
