Latuda lurasidone: Additional Phase III data

Additional data from the double-blind, international Phase III PREVAIL 1 trial in 348 patients with bipolar I depression showed that once-daily 20-120 mg Latuda as an add-on to lithium or valproate significantly reduced MADRS scores from baseline to week 6, the primary endpoint, by 17.1 points vs. 13.5 points for placebo (p<0.01). On secondary endpoints, Latuda significantly reduced CGI-BP-S and HAM-A scores from baseline to week 6 by 2 and 8 points, respectively, vs. 1.5 and 6 points for placebo (p<0.01 for both). Additionally, 57% of patients receiving Latuda achieved a >=50% reduction in MADRS score vs. 42% for placebo (p<0.01). Furthermore, Latuda significantly reduced SDS scores from baseline to week 6 by 9.5 points vs. 7 points for placebo (p<0.05), and significantly increased Q-LES-Q-SF scores by 22.2 points vs. 15.9 points for placebo (p<0.01). Data were presented at the American Psychiatric Association meeting in Philadelphia. ...