Lexapro (escitalopram oxalate)
Company: Forest Laboratories
Approval Status: Approved August 2002
Treatment for: major depression
Areas: Psychiatry/Psychology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
In August 2002, the FDA approved Lexapro for the treatment of major depressive disorder. Lexapro's efficacy and tolerability have been proven in clinical trials. The recommended dose of Lexapro is 10 mg daily.
Lexapro (escitalopram oxalate), an orally administered selective serotonin reuptake inhibitor (SSI), is indicated for the treatment of major depressive disorder. Lexapro is the single-active isomer of Celexa, a racemic mixture with two mirror-image halves called the S- and R-enantiomers.
Each year, nearly 19 million adult Americans suffer from depression. According to the predictios of the World Health Organization depression will become the leading cause of disability by the year 2020.
Forest Laboratories licensed Lexapro from the Danish pharmaceutical firm, H. Lundbeck A/S, which developed both citalopram and escitalopram in Europe.
Clinical Results
Lexapro's approval was based on a double-bind, placebo-controlled, multi-center study that involved 491 subjects with ongoing major depressive episodes. The subjects were randomized for eight weeks to one of four trial arms: placebo, Lexapro at 10 mg per day, Lexapro at 20 mg per day, or Celexa at 40 mg per day.
The results showed that Lexapro at 10 mg per day and 20 mg per day demonstrated significantly greater improvement relative to placebo. Additionally, Lexapro 10 mg was shown to be as effective as 40 mg of Celexa on the major efficacy outcome variables. Summarily, Lexapro was statistically superior to placebo in all common efficacy measures, beginning at week one and continuing throughout the study period. All treatment groups had a low rate of discontinuation due to adverse events.
Side Effects
Adverse events associated with the use Lexapro may include (but are not limited to) the following:
- nausea
- insomia
- fatigue
- somnolence
- sweating increased
- ejaculation disorder
Mechanism of Action
Lexapro, a single isomer of Celexa, is an orally administered selective serotonin reuptake inhibitor (SSI).
Additional Information
For additional information on Lexapro, please visit the The Forest Laboratories web site.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
