Latuda lurasidone: Additional Phase III data

Additional data from the double-blind, international Phase III PREVAIL 2 trial in 505 patients with bipolar I depression showed that both once-daily 20-60 and 80-120 mg Latuda as monotherapy significantly reduced MADRS scores from baseline to week 6, the primary endpoint, by 15.4 points vs. 10.7 points for placebo (p<0.001 for both). On secondary endpoints, low- and high-dose Latuda significantly reduced CGI-BP-S scores from baseline to week 6 by 1.8 and 1.7 points, respectively, vs. 1.1 points for placebo (p<0.001 for both), and significantly reduced HAM-A scores by 6.8 and 6.3 points, respectively, vs. 4.6 points for placebo (p<0.05 for both). Additionally, 53% and 51% of patients receiving low- and high-dose Latuda achieved a >=50% reduction in MADRS score vs. 30% for placebo (p<0.001 for both). Furthermore, low- and high-dose Latuda significantly reduced SDS scores from baseline to week 6 by 9.5 and 9.8 points, respectively, vs. 6.3 points for placebo (p<0.01 for both), and significantly increased Q-LES-Q-SF scores by 19.3 and 19.8 points, respectively, vs. 12.8 points for placebo (p<0.01 for both). Data were presented at the American Psychiatric Association meeting in Philadelphia. ...