Forest Laboratories and Lundbeck announces positive results of Lexapro phase III study in adolescents with major depression
Forest Laboratories, Inc. and H. Lundbeck A/S announced preliminary top-line results from a phase III study of Lexapro® (escitalopram oxalate) in the treatment of adolescents, aged 12-17, with major depressive disorder (MDD). These results indicate that patients treated with Lexapro® experienced statistically significant improvement in symptoms of depression, as measured by the study's primary endpoint, the Children's Depression Rating Scale-Revised (CDRS-R), compared to placebo.
The CDRS-R is a commonly used clinician-rated instrument that covers 17 symptom areas of depression relevant to adolescents, including impaired schoolwork, difficulty having fun, social withdrawal, physical complaints, and low self-esteem. Additional data from this study are expected to be presented in 2008.
Researchers estimate that up to eight percent of adolescents are affected by depression. However, FDA-approved treatment options for this population are limited. Lexapro® is not currently approved by the FDA for use in pediatric patients.
Subject to ongoing communication with the FDA and review of the full study results for the just completed trial, Forest Laboratories, Inc. intend to file in 2008 for an adolescent depression indication for Lexapro®.
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