Sunovion announced that the Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Latuda (lurasidone HCl) for the treatment of schizophrenia in adolescents aged 13–17 years.
Latuda, an atypical antipsychotic, is already approved 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 expanded approval was based on data from a 6-week randomized, double-blind, placebo-controlled study where adolescent patients with schizophrenia received fixed doses of Latuda 40mg daily, Latuda 80mg daily, or placebo. At the study’s endpoint, the 40mg and 80mg doses were associated with a statistical and clinical improvement in symptoms of schizophrenia vs. placebo. The study also showed Latuda was also generally well tolerated with minimal 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 Robert Findling, MD, MBA, Vice President of Psychiatric Services and Research at the Kennedy Krieger Institute, Director of Child and Adolescent Psychiatry at the Johns Hopkins University School of Medicine and a study investigator.
Latuda is available as 20mg, 40mg, 60mg, 80mg, and 120mg strength tablets in 30-, 90-, and 500-count bottles.
For more information call (800) 739-0565 or visit Latuda.com.