Escitalopram Oxalate for Generalized Anxiety Disorder
Forest Laboratories, Inc., has announced that it has received an approvable letter from the FDA to expand the use of esci-talopram oxalate (Lexapro drug) to include the treatment of generalized anxiety disorder (GAD).
Lexapro™, a selective serotonin re-uptake inhibitor (SSRI), 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 with GAD, was submitted to the FDA in November 2002. Forest expects to launch Generic Lexapro to treat GAD in early 2004 after final approval.
GAD is characterized by excessive anxiety about everyday events or activities for a period of six months or more. This constant worry affects daily functioning and can cause physical symptoms. GAD often co-occurs with mood disorders, including depression. In addition, up to 80% of depressed people also experience anxiety.
As with all SSRIs, the drug should not be taken with monoamine oxidase inhibitors.
