Sumitomo Dainippon Pharma Co., Ltd. announced that topline results from a Phase III clinical study evaluating lurasidone hydrochloride (generic name, "lurasidone"), an atypical antipsychotic in the treatment of patients with schizophrenia met its primary endpoint and demonstrated a favorable tolerability profile of lurasidone. The Phase III study was conducted to support regulatory approval in Japan. This study was a multi-center, placebo-controlled, randomized, double-blind, 6-week study intended to evaluate the efficacy and safety of lurasidone 40 mg/day vs. placebo, involving 483 patients with schizophrenia. Using the pre-specified primary analysis in the ITT (Intent to Treat) population (n=478), the lurasidone group (245 patients) demonstrated statistically significant improvement compared to the placebo group (233 patients) in the primary endpoint of change from baseline of the PANSS (Positive and Negative Syndrome Scale) total score after 6 weeks of study treatment [-19.3 in the lurasidone group and -12.7 in the placebo group (p<0.001)]. Based on the results of this study, as well as the completed Phase III study involving patients with bipolar l depression*3, Sumitomo Dainippon Pharma plans to submit new drug applications for approval of manufacturing and marketing of lurasidone for the treatment of patients with schizophrenia and bipolar depression in Japan, in the first half of 2019.