FDA Approves Supplemental NDA for Schizophrenia Drug for Teens

Based on results from a six-week study, the US Food and Drug Administration (FDA) approved using lurasidone HCl (Latuda/Sunovion) to treat adolescents 13 to 17, the manufacturer announced today. The product is already approved for adult use, both for schizophrenia and major depressive disorders associated with bipolar depression. It is also approved as adjunctive therapy with lithium or valproate.

"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 Robert Finding, MD, MBA, of the Kennedy Krieger Institute and Director of Child and Adolescent Psychiatry at Johns Hopkins University School of Medicine, a study investigator.

According to a news release from the company the drug given at 40 mg per day and 80 mg per day doses resulted in statistical and clinical improvement in symptoms compared to placebo.

The approval gives physicians a new drug to use for adolescents with these disorders, the first such new product in five years.

Adolescents who have schizophrenia can have more severe onset of psychotic symptoms than comparable adults.

Also, delays to treatment may be two or three times longer for teens than for adults, resulting in poorer treatment outcomes and a less robust response to therapy.

The announcement was made in a news release from the company.