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FDA Grants Approvable Letter for Lexapro (Escitalopram Oxalate), Treatment of Generalized Anxiety Disorder
NEW YORK, NY -- September 29, 2003 -- Forest Laboratories, Inc. (NYSE: FRX) announced today that it has received an approvable letter from the United States Food and Drug Administration (FDA) to expand the use of Lexapro™ (escitalopram oxalate) to include the treatment of generalized anxiety disorder (GAD). Lexapro is the newest and most selective serotonin reuptake inhibitor (SSRI), and is currently indicated for the initial and maintenance treatment of major depressive disorder. A supplemental New Drug Application (sNDA), which was based on three placebo-controlled studies in patients suffering from GAD, was submitted to the FDA in November 2002.
The approvable letter involves resolution of routine matters and therefore Forest continues to expect to launch Lexapro for GAD in early 2004 subject to final approval.
About Generalized Anxiety Disorder
Anxiety disorders are the most common mental illness in the U.S., affecting 19.1 million adults, and they cost the U.S. more than $42 billion a year. The prevalence of generalized anxiety disorder (GAD) is estimated to be 4 million or 2.8% of the U.S. population, and it affects women twice as often as men. According to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), the essential feature of GAD is excessive anxiety and worry (apprehensive expectations) about every day events or activities for a period of six months or more. This constant worry affects daily functioning and can cause physical symptoms. For a diagnosis to be made, worry must be present more days than not for at least six months. GAD frequently co-occurs with mood disorders, including depression. Additionally, up to 80% of people suffering from depression also experience symptoms of anxiety.
About Lexapro
Lexapro is the newest and fastest-growing selective serotonin reuptake inhibitor (SSRI). Lexapro was developed by isolating the therapeutically active portion of the antidepressant Celexa™ (citalopram HBr). Lexapro was approved by the U.S. Food and Drug Administration (FDA) in August 2002 for both the initial and maintenance treatment of major depressive disorder. Lexapro is available as tablets and oral solution.
As with all SSRIs, Lexapro should not be taken together with monoamine oxidase inhibitors (MAOI). For more information about Lexapro, please visit http://www.lexapro.com.
Forest Laboratories licenses Lexapro from the Danish pharmaceutical firm H. Lundbeck A/S, which developed escitalopram and citalopram.
SOURCE: Forest Laboratories, Inc.
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