BioCentury
ARTICLE | Clinical News

Latuda lurasidone: Updated Phase III data

May 18, 2015 7:00 AM UTC

Sumitomo said updated data from the double-blind, Asian Phase III PASTEL trial of lurasidone no longer support approval of the product to treat schizophrenia in Japan. In 439 patients in the modified intent-to-treat (mITT) population of the trial, updated data showed that once-daily lurasidone non-significantly reduced PANSS total score from baseline to week 6, the primary endpoint, by 17.9 points at the 40 mg dose and by 17.3 points at the 80 mg dose vs. 13.1 points for placebo. Sumitomo previously reported data from 430 patients in the mITT population showing that low-dose lurasidone met the primary endpoint of reducing PANSS total score from baseline to week 6 vs. placebo (18.1 vs. 13 points), and that high-dose 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 (see BioCentury, Jan. 12, 2015). ...