FDA Expands Latuda Label to Include Treatment of Adolescents With Schizophrenia

Atypical antipsychotic was previously approved only for adults

The FDA has approved a supplemental new drug application for lurasidone (Latuda, Sunovion Pharmaceuticals), an atypical antipsychotic, for the treatment of schizophrenia in adolescents 13 to 17 years of age. Lurasidone is also indicated in the United States for the treatment of adults with schizophrenia and for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

The new approval was based on results from a six-week, randomized, double-blind, placebo-controlled study in which adolescents with schizophrenia received fixed doses of lurasidone 40 mg/day, lurasidone 80 mg/day, or placebo. At the study endpoint, the lurasidone dosages of 40 mg/day and 80 mg/day were associated with statistical and clinical improvements in symptoms of schizophrenia compared with placebo. Lurasidone was also generally well tolerated, with limited effects on weight and metabolic parameters.

Although schizophrenia is rare in young children, its incidence rises during adolescence and peaks in early adulthood. Adolescent schizophrenia is associated with poor functioning before the onset of illness and early developmental delays. Similar types of early developmental and social impairments have been reported in adult-onset schizophrenia, but they appear to be more common and severe in adolescents. A diagnosis of schizophrenia in adolescence may be a predictor of less independence, poorer educational achievement, lower likelihood of employment or access to further education, higher global disability scores, and poor social relationships in adulthood.

Source: Sunovion Pharmaceuticals; January 28, 2017.