Sunovion announced results of two pivotal trials supporting the FDA approval of Latuda (lurasidone HCl) for the treatment of adults with major depressive episodes associated with bipolar I disorder, both as montherapy and as adjunctive therapy with lithium or valproate.
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.
Patients who received Latuda monotherapy in the dose range of 20–60 mg/day or 80–120 mg/day experienced a statistically significant reduction in mean change from baseline at Week 6 in MADRS total scores compared with placebo (-15.4 and -15.4 vs. -10.7; P<0.001; mixed model for repeated measures (MMRM) analysis), the primary efficacy endpoint of the study.
In the other study, patients were randomized to receive adjunctive treatment with Latuda (N=183) or placebo (N=165), added to background treatment with lithium or valproate. Patients who received Latuda in the dose range of 20–120 mg/day as adjunctive therapy with lithium or valproate showed a statistically significant reduction in the primary efficacy endpoint, change from baseline at Week 6 in MADRS total scores compared with placebo (-17.1 vs. -13.5; P=0.005; MMRM analysis).
Latuda is approved for the treatment of depressive episodes associated with bipolar I disorder alone or with lithium or valproate and for the treatment of schizophrenia.
For more information call (800) 739-0565 or visit Latuda.com.