Tuesday, January 31, 2017

FDA Approves Latuda for Use in Adolescents With Schizophrenia

The Food and Drug Administration (FDA) on Friday approved a supplemental New Drug Application for Latuda (lurasidone HCl) for the treatment of schizophrenia in adolescents aged 13 to 17 years. 

Latuda is already approved 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.

According to a statement on the website of Sunovion, which manufactures Latuda, the approval is based on results from a randomized, double-blind, placebo-controlled, six-week study in which adolescent patients with schizophrenia received fixed doses of Latuda 40 mg/day, Latuda 80 mg/day, or placebo. At study endpoint, Latuda 40 mg/day and 80 mg/day were associated with statistical and clinical improvement in symptoms of schizophrenia compared with placebo. Latuda was also generally well tolerated with limited effects on weight and metabolic parameters. 

“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,” said study investigator Robert Findling, M.D., M.B.A., director of child and adolescent psychiatry at the Johns Hopkins University School of Medicine, in the Sunovion statement. “The availability of Latuda provides health care providers with an important new option for helping adolescents with this illness that is chronic and severely disabling.”

For related information, see the Psychiatric News article “Early Intervention Trial in Youth at Risk for Psychosis Shows Improved Symptoms.”

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