Lurasidone approved for bipolar depression treatments

The FDA has approved two new indications for the atypical antipsychotic drug lurasidone in the treatment of adult patients with major depressive episodes associated with bipolar I disorder, according to a press release from the company marketing the drug.

Lurasidone (Latuda, Sunovion) is now approved as monotherapy or as an adjunctive therapy with either lithium or valproate.

In two 6-week clinical trials, the results of which were presented during the American Psychiatric Association's annual meeting in San Francisco in May, lurasidone (20 mg to 120 mg per day) was associated with significant reductions in depressive symptoms vs. placebo and improvements in secondary endpoints, including anxiety, rates of remission and quality of life.

Adverse events associated with the treatment included akathisia, extrapyramidal symptoms, somnolence, nausea, vomiting, diarrhea and anxiety, according to the company. Patients also experienced changes in weight, BMI, lipid parameters and measures of glycemic control.

"The pharmacological profile of Latuda, together with preclinical and initial clinical findings, suggested the potential for efficacy in depressive episodes associated with bipolar disorder," Antony Loebel, MD, executive vice president and chief medical officer of Sunovion Pharmaceuticals Inc., said in the press release. "Historically, it has been difficult to show efficacy in clinical trials for the treatment of bipolar depression, but we felt strongly it was the right path to take given the high unmet need. We are pleased that the two new Latuda indications for monotherapy and adjunctive treatment of bipolar depression are supported by robust evidence demonstrating efficacy and safety."