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Lexapro receives FDA approval for the treatment of generalized anxiety disorder

NEW YORK, December 18 - Forest Laboratories, Inc. (NYSE:FRX) announced today that the U.S. Food and Drug Administration (FDA) has approved Lexapro (escitalopram oxalate), a selective serotonin reuptake inhibitor (SSRI), for the treatment of generalized anxiety disorder (GAD), a condition that affects approximately four million Americans annually. The new indication is based on three studies, all of which were positive and support the efficacy and safety of Lexapro in the treatment of GAD. GAD is characterized by excessive anxiety and worry that significantly impacts an individual's daily functioning. Lexapro is also indicated for the initial treatment and maintenance of major depressive disorder.

"One of the biggest challenges in treating GAD patients is finding a treatment that is not only effective, but also one that patients will be able to tolerate for the long term," said Philip Ninan, M.D., professor of Psychiatry and Behavioral Sciences and director of the Mood and Anxiety Disorders Program at Emory University School of Medicine. "Lexapro is a first-line treatment option, which has proven to be effective with a favorable side effect profile."

Study Details

All three studies that support the indication approval were randomized, double-blind, eight weeks in duration and placebo-controlled. The studies involved approximately 850 patients, 18 to 80 years of age, diagnosed with GAD. Patients in the Lexapro arm were administered a fixed dose of 10 mg per day for the first four weeks and then flexibly dosed to a maximum of 20 mg per day. The Hamilton Anxiety Scale (HAMA) total score was the primary efficacy variable, and secondary efficacy measures included changes in HAMA psychic anxiety subscale and Clinical Global Impressions (CGI) scores. In each of the three studies, Lexapro 10 to 20 mg per day significantly improved GAD symptoms in patients compared to placebo as measured by change from baseline in HAMA score. By-visit anal
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Contact: Charles E. Triano
212-224-6714
Forest Laboratories
18-Dec-2003


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