The US Food and Drug Administration (FDA) has approved a supplemental new drug application for lurasidone (Latuda) for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) in children and adolescents aged 10 to 17 years.

Lurasidone, a serotonin dopamine antagonist, is already approved in the United States for the treatment of adults with bipolar depression as monotherapy and as adjunctive therapy with lithium or valproate, and for the treatment of schizophrenia in adults and children aged 13 to 17 years.

The safety and efficacy of lurasidone for bipolar depression in children aged 10 to 17 years were assessed in a 6-week, randomized, double-blind, placebo-controlled study. A total of 347 participants received once-daily lurasidone (20 to 80 mg/day) or placebo.

Lurasidone is available as a tablet in five strengths: 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. Lurasidone is manufactured by Sunovion Pharmaceuticals Inc.

The company notes that the effectiveness of lurasidone for longer-term use (>6 weeks) has not been established in controlled studies. It advises physicians who elect to use lurasidone for extended periods to periodically reevaluate the long-term usefulness of the drug for the individual patient. The efficacy of lurasidone in the treatment of mania associated with bipolar disorder has not been established.

Full prescribing information is available online.