Forest Laboratories Inc 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.
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.