Sunovion announced that the FDA has approved two new indications for Latuda (lurasidone HCl) to treat adults with major depressive episodes associated with bipolar I disorder (bipolar depression) both as monotherapy and adjunctive therapy with either lithium or valproate.

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The approval is supported by two positive double-blind, randomized, placebo-controlled, six-week clinical trials for the treatment of adults with bipolar depression both as monotherapy (PREVAIL 2) and as adjunctive therapy (PREVAIL 1). Study results showed that Latuda demonstrated statistically significant reductions in Montgomery-Asberg Depression Rating Scale (MADRS) scores at study endpoint compared to placebo.

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

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