FDA approves Latuda (Sunovion Pharmaceuticals) for Bipolar Disorder

The FDA has approved two indications for the use of Latuda (lurasidone HCl), from Sunovion Pharmaceuticals, as monotherapy and adjunctive therapy with either lithium or valproate, both to treat adult patients with major depressive episodes associated with Bipolar I Disorder (Bipolar Depression). Two positive double-blind, randomized, placebo-controlled, six-week clinical trials supported the two new indications, as monotherapy (PREVAIL 2) and as adjunctive therapy (added to background treatment with lithium or valproate) (PREVAIL 1).

Both studies showed that treatment resulted in statistically significant reductions in MADRS scores at study endpoint compared to placebo, with significant separation from placebo observed as early as Week 2 of treatment. Additionally, across both studies, patients receiving Latuda demonstrated statistically significant improvements vs. placebo at Week 6 on secondary endpoints, including CGI-BP-S, responder rates, rates of remission, anxiety symptoms, self-assessment of depression, as well as measures of functionality and quality and enjoyment of life.