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Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents
Date:3/20/2009

ek, 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, MD, 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.

Depression and Adolescents

Depression in adolescents, as in adults, is a serious disease that requires medical treatment. Approximately 2 million U.S. adolescents aged 12 to 17 have suffered a serious bout of depression in the pa
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SOURCE Forest Laboratories, Inc.
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