Sunovion Publishes Latuda Data

Sunovion Pharmaceuticals has published results in The American Journal of Psychiatry (AJP) of two trials supporting the FDA approval of Latuda (lurasidone HCl) for the treatment of adult patients with major depressive episodes associated with bipolar depression, both as monotherapy and as adjunctive therapy with lithium or valproate

The two positive double-blind, randomized, placebo-controlled, six-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.

Across both studies, Latuda demonstrated statistically significant improvements vs. placebo at Week 6 on all other secondary endpoints including: responder rates; rates of remission; Hamilton Anxiety Rating Scale (HAM-A); Sheehan Disability Scale (SDS); Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16); and Quality of Life, Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF).