Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Sch...( - The company plans to submit a New D...),Health

- The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in 2010 -

SAN FRANCISCO, May 20 /PRNewswire/ -- Dainippon Sumitomo Pharma Co., Ltd., (DSP) announced today positive results from the first phase 3 clinical trial for lurasidone, which is under clinical development globally, for the treatment of patients with schizophrenia. In this six-week, double-blind, placebo-controlled trial, lurasidone 80 mg/day was significantly more effective than placebo for the treatment of acute schizophrenia. In addition, lurasidone was well-tolerated and had a relatively low discontinuation rate. The findings were presented at the 162nd Annual Meeting of the American Psychiatric Association in San Francisco, held on May 16-21.

PEARL 1 (Program to Evaluate the Antipsychotic Response to Lurasidone) is part of an extensive worldwide phase 3 clinical development program, involving more than 2,000 patients, intended to evaluate the safety and efficacy of lurasidone for the treatment of schizophrenia. In addition to the primary finding that lurasidone 80 mg/day was significantly more effective than placebo at the study endpoint, lurasidone was associated with greater improvement on both the Positive and Negative Syndrome Scale (PANSS) total score (primary endpoint) and the Clinical Global Impressions Severity scale (CGI-S, key secondary endpoint) at all visits between weeks two and six. PEARL 1 also evaluated two other fixed doses of lurasidone, 40 mg/day and 120 mg/day, which did not demonstrate separation from placebo on the PANSS or CGI-S at study endpoint.

"People with schizophrenia need new treatment options that offer a combination of efficacy, safety and tolerability so that the symptoms can be stabilized and effectively treated," said Henry Nasrallah, M.D., professor of psychiatry and neuroscience and director of the schizophrenia rese
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