FDA approves escitalopram oxalate for acute, maintenance treatment of MDD in adolescents.

Following an AP story, Medscape (3/23, Hitt) reported that “escitalopram oxalate (Lexapro, Forest Laboratories, Inc.) has been approved by the US Food and Drug Administration (FDA) for the acute and maintenance treatment of major depressive disorder (MDD) in adolescents aged 12 to 17 years.” The FDA granted approval “based on data from two flexible-dose, placebo-controlled trials that each lasted eight weeks. One trial was conducted in adolescents aged 12 to 17 years and compared escitalopram with placebo,” while “the other trial was conducted in children and adolescents aged seven to 17 years and compared citalopram with placebo.” The results of both studies demonstrated “a significant improvement in the Children’s Depression Rating Scale-Revised (CDRS-R) in the treatment group compared with the placebo group,” with the “greatest benefit” being “observed in the adolescent group.”