(dailyRx News) Forest Laboratories, Inc. has announced that the FDA has approved the company's supplemental New Drug Application (sNDA) for Lexapro (escitalopram oxalate) for the acute and maintenance treatment of major depressive disorder (MDD) in adolescents 12 to 17 years of age.
Lexapro is only the second antidepressant to be approved for treating MDD in adolescents, a medical condition that affects approximately 2 million adolescents in the U.S.
The approvalwas supported by two placebo-controlled studies, one conducted in adolescent patients taking Lexapro and one conducted in children and adolescents taking citalopram (Celexa). In an eight-week flexible-dose, placebo-controlled study that compared Lexapro 10-20 mg/day to placebo in 12- to 17-year-old patients reported in 2008, Lexapro showed statistically significant greater mean improvement from baseline, compared to placebo, on the Children's Depression Rating Scale-Revised (CDRS-R).
In another eight-week, flexible-dose, placebo-controlled study, children and adolescents 7 to 17 years of age treated with racemic citalopram 20-40 mg/day showed statistically significant greater mean improvement from baseline on the CDRS-R compared to patients treated with placebo. The positive results for this trial largely came from the adolescent subgroup. The FDA's determination of the efficacy of Lexapro in the acute treatment of MDD in adolescents was established, in part, on the basis of extrapolation from this study.
Two additional flexible-dose, placebo-controlled MDD studies were conducted: one Lexapro study in patients ages 7 to 17 and one citalopram study in adolescents. Neither study demonstrated efficacy on the primary efficacy parameter.
Although maintenance efficacy in adolescent patients has not been systematically evaluated, the FDA in its review concluded that maintenance efficacy can be extrapolated from adult data along with comparisons of escitalopram pharmacokinetic parameters in adults and adolescent patients.
Lexapro was generally well tolerated. The overall profile of adverse reactions in pediatric patients was generally similar to that seen in adult studies and is described in the package insert.
"Adolescent depression can often be challenging to treat because there are limited treatment options that are proven to be effective and well-tolerated in this patient population," said Graham Emslie, M.D., professor of psychiatry at the University of Texas Southwestern Medical Center in Dallas. "The FDA approval of Lexapro for adolescents is a significant development for the patients who struggle with this illness every day."
Frank J. Murdolo