Dainippon Sumitomo Pharma Co., Ltd. (DSP) announced today results from two Phase 3 clinical trials designed to evaluate the efficacy and safety of LATUDA as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone). On an overall basis in both studies, patients with bipolar I depression treated with LATUDA experienced statistically significant improvements in symptoms of depression, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS), compared to patients taking placebo. In both trials, on an overall basis, patients in the LATUDA treatment arms experienced low changes in weight, lipids and measures of glycemic control.
“Bipolar I depression is highly debilitating for many patients”
"We believe these data show LATUDA may help patients with bipolar I depression," said Masayo Tada, Representative Director, President and Chief Executive Officer, Dainippon Sumitomo Pharma Co., Ltd. "With both studies meeting their primary endpoints, we remain on track to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for LATUDA in bipolar I depression by the end of 2012."
"Bipolar I depression is highly debilitating for many patients," said Gary Sachs, M.D., Founding Director of the Bipolar Clinic and Research Program at Massachusetts General Hospital in Boston, Massachusetts in the United States. "The efficacy and adverse effect data obtained in these studies suggest LATUDA may be a useful treatment option for patients with bipolar I depression."
LATUDA is not approved by the FDA for the treatment of bipolar disorder, including bipolar I depression. LATUDA is only approved by the FDA in the U.S. for the treatment of adult patients with schizophrenia. The safety and efficacy of LATUDA has not yet been established in bipolar I depression. The use of LATUDA outside its approved indication in the PREVAIL 1 and PREVAIL 2 studies has been carefully controlled and monitored to better understand the potential benefits and risks of the compound in the treatment of bipolar I depression. A number of factors, including the FDA regulatory review process, impact whether or not a drug product or indication will ultimately be commercialized in the U.S. Given these uncertainties, there can be no assurances that LATUDA will become commercially available for bipolar I depression in the U.S., or for any additional indications anywhere in the world.
Dainippon Sumitomo Pharma Co., Ltd.