Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Psychiatry/Psychology | Family Medicine
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Lexapro (escitalopram oxalate)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Forest Laboratories
Approval Status: Approved August 2002
Treatment Area: major depression
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.
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.
Adverse events associated with the use Lexapro may include (but
are not limited to) the following:
- sweating increased
- ejaculation disorder
Mechanism of Action
Lexapro, a single isomer of Celexa, is an orally administered
selective serotonin reuptake inhibitor (SSI).