JEWEL study of lurasidone for the treatment of patients with schizophrenia met its primary endpoint.- Sumitomo Dainippon

Sumitomo Dainippon Pharma Co., Ltd. announced that topline results from a Phase III clinical study (JEWEL study, �this 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)]. in addition, the lurasidone group demonstrated statistically significant improvement compared to the placebo group on the change from baseline of the clinical global impressions severity scale (cgi-s) after 6 weeks, a secondary efficacy endpoint. in this study, lurasidone was generally well-tolerated, and adverse events (aes) observed in the lurasidone group were generally mild and consistent with prior studies of lurasidone in patients with schizophrenia.>

The incidences of AEs in the lurasidone group and the placebo group were 47.0% and 51.1%, respectively. Fewer patients discontinued the study treatment in the lurasidone group (19.4%) than in the placebo group (25.4%). Similar proportions of patients in the lurasidone and placebo groups discontinued due to AEs (5.7% and 6.4%, respectively).