Lurasidone HCl, marketed as Latuda, has received approval from the Food and Drug Administration for the treatment of schizophrenia in adolescents aged 13-17 years old, according to a press release from Sunovion Pharmaceuticals.
FDA approval of Latuda is based on results of a 6-week study in which adolescents with schizophrenia received either 40 mg of lurasidone per day, 80 mg per day, or a placebo. Patients who received lurasidone HCI showed statistical and clinical improvements in schizophrenia symptoms, compared with the placebo group. The drug was well tolerated with no significant adverse events reported.
Lurasidone HCl previously has been approved to treat schizophrenia in adults, as well as for treatment of major depressive episodes in adults with bipolar disorder I, either alone or 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,” Robert L. Findling, MD, study investigator, and director of child and adolescent psychiatry at Johns Hopkins University, Baltimore, said in the press release. “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,” said Dr. Findling, also vice president of psychiatric services and research at the Kennedy Krieger Institute, Baltimore.
Find the full press release on the Sunovion Pharmaceuticals website .