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news.Sunovion Pharmaceuticals has submitted two supplemental new drug applications (sNDAs) to the FDA 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.
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These sNDAs are based on two six-week, double-blind, placebo-controlled Phase 3 clinical trials, PRogram to EValuate the Antidepressant Impact of Lurasidone (PREVAIL) 1 and PREVAIL 2.
Sunovion Pharmaceuticals vice chair Hiroshi Nomura said if LATUDA is approved both for monotherapy and for adjunctive therapy of bipolar depression, it will be a first for the atypical class of drugs.
"The PREVAIL program demonstrates the company’s continued commitment to the development of new treatments for people living with serious mental illness," Nomura added.
The results from the PREVAIL 1 and PREVAIL 2 studies suggest that LATUDA may be a useful treatment option for adult patients with bipolar depression.
Sunovion executive vice president and chief medical officer Antony Loebel said, "Bipolar depression is a severely debilitating illness that disrupts the lives of many patients, yet there are currently few treatment options that have successfully demonstrated efficacy in clinical trials."