FDA accepts Sunovion’s two LATUDA sNDAs for review

Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental New Drug Applications (sNDAs) for the use of LATUDA 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). The acceptance of these files indicates that the FDA has determined that the applications are sufficiently complete to permit a substantive review.

"In recent years, we have witnessed a reduction in research and development for psychiatric disorders, including bipolar disorder, leaving patients and the physicians who treat them with few treatment advancements," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer, Sunovion Pharmaceuticals Inc. "This milestone further underscores Sunovion's continued commitment to the development of new treatments that can address unmet needs for patients with serious mental illness."

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), involving 852 people suffering from bipolar depression.

LATUDA is not approved by the FDA for the treatment of adult patients with depressive episodes associated with bipolar I disorder (bipolar depression). LATUDA is approved for the treatment of adult patients with schizophrenia in the U.S. and in Canada.