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ARTICLE | Clinical News

Latuda lurasidone: Preliminary Phase III data

January 12, 2015 8:00 AM UTC

Preliminary data from 430 patients in the modified intent-to-treat (mITT) population of the double-blind, Asian Phase III PASTEL trial showed that once-daily 40 mg lurasidone met the primary endpoint of reducing PANSS total score from baseline to week 6 vs. placebo (18.1 vs. 13 points). In the mITT population, the once-daily 80 mg dose of lurasidone non-significantly reduced PANSS total score from baseline to week 6 by 17.5 points. The mITT population excluded any scores that were evaluated within 12 hours after the use of lorazepam or hypnotic drugs.

Data from 446 patients in the ITT population showed that both low- and high-dose lurasidone met the primary endpoint of reducing PANSS total score from baseline to week 6 vs. placebo (17.8 and 17.3 points, respectively, vs. 12.1 points). Neither dose of lurasidone met the secondary endpoint of improving CGI-S score from baseline to week 6 vs. placebo. Sumitomo plans to submit a regulatory application in Japan for lurasidone to treat schizophrenia. ...