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news.Dainippon Sumitomo Pharma's schizophrenia drug lurasidone hydrochloride did not show improvement in the symptoms of depression in patients when compared to placebo over the 6-week study endpoint.
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The double-blind, placebo-controlled, six-week clinical trial (with an active comparator) was conducted in Japan, Korea and Taiwan.
Subjects were randomized to four arms – placebo (129 subjects), lurasidone 40 mg/day (125 subjects), lurasidone 80 mg/day (129 subjects) and established active comparator (64 subjects).
Efficacy of lurasidone was evaluated using the Positive and Negative Syndrome Scale (PANSS) total score as the primary endpoint and the Clinical Global Impressions Severity scale (CGI-S) as the secondary endpoint.
Lurasidone did not demonstrate a statistically improvement vs placebo in PANSS total score change at the 6-week study endpoint, despite a reduction of the total PANSS score after treatment with lurasidone at 40 mg/day and 80 mg/day.
Dainippon Sumitomo Pharma president and CEO Masayo Tada said while the results of this study were unexpected for lurasidone, based on prior clinical experience with the product they remain highly confident in the development plan for lurasidone in Japan.
"Building upon the clinical success and approval of lurasidone in the US, we believe we obtained useful data as a result of conducting the trial that will assist us with the design of future studies to support the registration of lurasidone in Japan," Tada said.
Dainippon Sumitomo Pharma plans to conduct a new Phase III study for lurasidone.