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Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia
Date:5/20/2009

-controlled, double-blind, multinational clinical trial evaluated the efficacy and safety of lurasidone 40 mg, 80 mg and 120 mg once daily compared to placebo, over six weeks in patients with acute schizophrenia. Patients were diagnosed with schizophrenia (using DSM-IV criteria) and were required to have an acute exacerbation of psychotic symptoms with a PANSS total score of 80 or higher at study baseline.

A total of 500 patients were randomized equally to the four treatment arms. The pre-specified primary endpoint was change from baseline in the PANSS total score over the six-week study duration for each lurasidone dose group vs. placebo. A key secondary endpoint was the change from baseline in CGI-S over the six-week study period. Efficacy data were statistically analyzed using a mixed model for repeated measures. Multiple safety assessments were done, including vital signs, weight, ECGs, movement disorder scales (SAS, BAS, AIMS), and laboratory assessments.

The study was conducted at 51 sites worldwide. Twenty-two sites in the United States randomized 278 patients, 21 sites in Europe randomized 148 patients and eight sites in Asia randomized 48 patients. The majority of trial participants were male with a mean age of 39 years. The mean time since initial diagnosis was approximately 14 years, and patients had, on average, four or more hospitalizations prior to study entry.

U.S. Placebo-Controlled Study Findings

Lurasidone has been studied in three double-blind, placebo-controlled, six-week trials involving more than 650 patients with schizophrenia, of which 392 patients received lurasidone. Two of the three studies demonstrated that lurasidone had superior efficacy compared to placebo at doses ranging between 40 mg and 120 mg/day. A third study, which examined three fixed doses of lurasidone (20 mg, 40 mg, and 80 mg/day) did not show statistical differences vs. placebo. This trial is
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SOURCE Dainippon Sumitomo Pharma Co., Ltd.
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