Dainippon Sumitomo's Latuda meets key endpoints in two Ph III trials in bipolar I depression

9 May 2012

Japanese drugmaker Dainippon Sumitomo Pharma (4506: JP) Co., Ltd. (DSP) announced has results from two Phase III clinical trials designed to evaluate the efficacy and safety of Latuda (lurasidone) as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone). Latuda is already approved in the USA for the treatment of schizophrenia (The Pharma Letter October 29, 2010).

On an overall basis in both studies, patients with bipolar I depression treated with LATUDA experienced statistically significant improvements in symptoms of depression, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS), compared to patients taking placebo. In both trials, on an overall basis, patients in the Latuda treatment arms experienced low changes in weight, lipids and measures of glycemic control.

On track for filing by year end

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