Latuda (Sunovion) success in studies for Bipolar Depression

Sunovion Pharmaceuticals Inc. announced that the results of two pivotal trials supporting the FDA approval of Latuda (lurasidone HCl) for the treatment of adult patients with Major Depressive Episodes associated with Bipolar I Disorder (bipolar depression), both as monotherapy and as adjunctive therapy with lithium or valproate, were published online in The American Journal of Psychiatry (AJP) on October 30, 2013.

The two positive double-blind, randomized, placebo-controlled, 6-week clinical trials showed that Latuda significantly reduced depressive symptoms in patients with bipolar depression, both as monotherapy and as adjunctive therapy, when compared to placebo as measured by the pre-specified primary endpoint of change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS).total score at Week 6. In addition, LATUDA was superior to placebo on the key secondary endpoint, change from baseline at Week 6 in the Clinical Global Impression-Bipolar Version-Severity of Illness (CGI-BP-S) score, which assessed global severity of depressive symptoms.