Sumitomo Dainippon’s lurasidone meets primary endpoint in Ph III study

Japanese drug major Sumitomo Dainippon Pharma (TYO: 4506) has released positive preliminary findings from a Phase III clinical study (PASTEL study) conducted for application for approval in Japan of lurasidone, an atypical antipsychotic in the treatment of patients with schizophrenia.

The study was a multicenter, placebo-controlled, randomized, double-blind six-week trial intended to evaluate the efficacy and safety of lurasidone, involving 457 patients with schizophrenia in three groups (about 150 patients in each group) of lurasidone 40mg/day, lurasidone 80 mg/day and placebo.

The primary endpoint of the study was change from the baseline of the Positive and Negative Syndrome Scale (PANSS) 1 total score, which was used to assess the efficacy of lurasidone compared to placebo. As a secondary endpoint, change from baseline in the Clinical Global Impressions-Severity of Illness Scale (CGI-S) was evaluated.