Latuda lurasidone: Phase III data

The double-blind, international Phase III RESOLVE 1 trial in 211 MDD patients who presented with a limited number of manic symptoms showed that flexibly-dosed, once-daily 20-60 mg Latuda met the primary endpoint of reducing MADRS total score from baseline to week 6 vs. placebo (20.5 vs. 13 points, p<0.0001). Latuda also met the secondary endpoint of reducing CGI-S score from baseline to week 6 vs. placebo (1.83 vs. 1.18 points, p<0.0001). Additionally, Latuda met all other secondary efficacy endpoints, including reducing manic symptoms as measured by YMRS score, vs. placebo. Data were presented at the American Psychiatric Association meeting in Toronto. ...