The Food and Drug Administration has approved lurasidone HCI (Latuda) for treating bipolar I depression in children and adolescents, according to a March 6 statement from the drug’s manufacturer.

“We know that children who have been diagnosed with bipolar depression can be at risk for poor school performance and impairments in social functioning,” said Robert L. Findling, MD, professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, in the statement .

“The FDA approval of this medicine for the treatment of pediatric patients with bipolar depression is significant for several reasons,” Dr. Findling said. “First, it is a new treatment option for this vulnerable group of young people. Also, it is the first single-agent formulation to receive regulatory approval for this pediatric indication.”

Approval of the atypical antipsychotic is based on results of a 6-week, randomized placebo-controlled phase 3 study of 347 children and adolescents diagnosed with bipolar I depression. Patients received either 20-80 mg/day of lurasidone or placebo.

Patients who received lurasidone reportedly experienced improved bipolar depression symptoms, compared with placebo, based on “the primary efficacy endpoint of change from baseline to week 6 on the Children’s Depression Rating Scale–Revised total score (–21.0 vs. –15.3; effect size = 0.45; P less than .0001),” the statement said. Clinically relevant changes also were found among patients who took the medication on other measures, including the Clinical Global Impressions-Bipolar Scale .

The most common adverse effects were nausea (16% vs. 5.8%), weight gain (6.9% vs. 1.7%), and insomnia (5.1% vs. 2.3%).

Lurasidone also has been approved for treating schizophrenia and bipolar I depression in adults. Last year, the drug was approved for treating schizophrenia in adolescents.


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