Sumitomo Dainippon Pharma is one step closer to securing regulatory approval in its native Japan for lurasidone after posting positive topline results from a Phase III clinical study.
Lurasidone (lurasidone hydrochloride) is an atypical antipsychotic in the treatment of patients with schizophrenia.
The treatment met its primary endpoint and demonstrated a favourable tolerability profile of lurasidone.
This study was a multi-centre, placebo-controlled, randomised, double-blind, 6-week study intended to evaluate the efficacy and safety of lurasidone 40 mg/day vs. placebo, involving 483 patients with schizophrenia.
Based on the results of this study, as well as the completed Phase III study involving patients with bipolar l depression, 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 FY2019.