SNDAs Submitted for Latuda for Bipolar Disorder

Sunovion announced that it has submitted two supplemental New Drug Applications (sNDAs) to the 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. The two 6-week, double-blind, randomized, placebo-controlled PREVAIL trials were designed to evaluate the efficacy and safety of Latuda as monotherapy (PREVAIL 2) and adjunctive therapy to lithium and valproate (PREVAIL 1), respectively, in adult patients with bipolar depression.

Latuda is an atypical antipsychotic agent indicated for the treatment of patients with schizophrenia.

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