Monday, July 1, 2013

Latuda Approved by USFDA for Adult Patients with Bipolar Depression

Sunovion Pharmaceuticals Inc. an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma Co., Ltd., today announced that the U.S. Food and Drug Administration (FDA) approved two new indications for the use of Latuda® (lurasidone HCl) as  1) monotherapy and 2) adjunctive therapy with either lithium or valproate, both to treat adult patients with major depressive episodes associated with bipolar I disorder (bipolar depression)

Clincial Evidence on Latuda (Lurasdione) in Bipolar Depression

Two positive double-blind, randomized, placebo-controlled, six-week clinical trials supported the two new indications for LATUDA for the treatment of adult patients with bipolar depression, both as monotherapy (PREVAIL 2) and as adjunctive therapy (added to background treatment with lithium or valproate) (PREVAIL 1). In both studies, the pre-specified primary endpoint was reduction in depressive symptoms, as measured by change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6. The key secondary endpoint (i.e., adjusted for multiple comparisons) was change from baseline in the Clinical Global Impression-Bipolar Version-Severity of Illness (CGI-BP-S) score at Week 6. Other secondary endpoints included changes from baseline at Week 6 in 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).

Efficacy of Latuda

Both studies showed that treatment with LATUDA 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.

Safety of Latuda

The most common adverse reactions (incidence ≥5%, in either dose group, and at least twice the rate of placebo) in patients receiving LATUDA as monotherapy were akathisia, extrapyramidal symptoms,
somnolence, nausea, vomiting, diarrhea, and anxiety; discontinuation rates due to any adverse reaction were 6.0% for LATUDA and 5.4% for placebo. In adjunctive treatment, the most common adverse reactions in patients receiving LATUDA (incidence ≥5% and at least twice the rate of placebo) were akathisia and somnolence; discontinuation rates due to any adverse reaction were 5.8% for LATUDA and 4.8% for placebo. Patients treated with LATUDA also experienced low rates of change in weight, body mass index (BMI), lipid parameters and measures of glycemic control.

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