FDA Approves Latuda for Bipolar Depression in Children and Adolescents

The Food and Drug Administration has approved Sunovion Pharmaceuticals’ Latuda (lurasidone HCl) for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in youth aged 10 to 17.

According to a press release from Sunovion, the approval for this expanded pediatric indication was based on data from a six-week, phase 3 clinical study of 347 children and adolescents with bipolar depression. After six weeks, the participants who received once-daily Latuda (20-80 mg/day) showed statistically significant improvements in depression symptoms compared with those taking placebo—as indicated by change from baseline on Children’s Depression Rating Scale, Revised (CDRS-R) total scores and Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) depression score.

The medication was generally well-tolerated, with nausea, weight gain, and insomnia being the most common adverse effects.

Latuda is already approved as a monotherapy or adjunctive therapy with lithium or valproate for the treatment of adults with bipolar depression. The medication is also approved for the treatment of adults and adolescents (aged 13 to 17) with schizophrenia. ■