Sunovion announced that the FDA has accepted two supplemental New Drug Applications (sNDAs) 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).
Efficacy was established in five six-week controlled studies of adult patients with schizophrenia. The sNDAs included data from two 6-week, double-blind, placebo-controlled, Phase 3 clinical trials, PREVAIL 1 and PREVAIL 2 (PRogram to EValuate the Antidepressant Impact of Lurasidone), evaluating 852 people suffering from bipolar depression.

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

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