The US Food and Drug Administration (FDA) has approved a supplemental new drug application for lurasidone (Latuda, Sunovion Pharmaceuticals Inc) for the treatment of schizophrenia in adolescents aged 13 to 17 years, the company has announced.
Lurasidone, a serotonin dopamine antagonist, is the first treatment to be approved in 5 years for adolescent patients with schizophrenia, the company noted in a news release.
Lurasidone is already approved in the United States for the treatment of adults with schizophrenia as well as adults with bipolar depression as monotherapy and as adjunctive therapy with lithium or valproate.
The FDA approval of lurasidone for adolescents with schizophrenia was based on a randomized, double-blind, placebo-controlled, 6-week study in which adolescents with schizophrenia received lurasidone 40 or 80 mg/day or placebo.
Both doses of lurasidone were associated with statistical and clinical improvement in symptoms of schizophrenia compared to placebo. Lurasidone was generally well tolerated, with limited effects on weight and metabolic parameters, the company said.
Past research has shown that psychosis that develops during adolescence may be more severe and is associated with a poorer prognosis than adult-onset schizophrenia. Delays in treatment after onset of psychotic symptoms may be two to three times longer for adolescents than adults and are associated with poorer treatment outcomes and response to treatment.
"The impact on development and poor prognosis frequently associated with schizophrenia that begins in adolescence underscores the need for treatment that is both well-tolerated and effective," Robert Findling, MD, vice president, psychiatric services and research, Kennedy Krieger Institute, and director of child and adolescent psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland, and a study investigator, said in the release.
"The availability of Latuda provides healthcare providers with an important new option for helping adolescents with this illness that is chronic and severely disabling," added Dr Findling.
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