Sunovion Pharmaceuticals Inc. Files Two Supplemental New Drug Applications Seeking Approval for the Use of Latuda® (lurasidone HCl) as Monotherapy and Adjunctive Therapy in Adult Patients With Depressive Episodes Associated With Bipolar I Disorder
Published: Sep 06, 2012
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. today announced that it has submitted two supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of LATUDA (lurasidone HCl) as 1) monotherapy and 2) adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with bipolar I disorder (bipolar depression). These sNDAs are supported by two 6-week, double-blind, placebo-controlled Phase 3 clinical trials, PREVAIL 1 and PREVAIL 2 (PRogram to EValuate the Antidepressant Impact of Lurasidone), involving 852 patients with bipolar depression.