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Lexapro receives FDA approval for treatment of major depression

Lexapro receives FDA approval for treatment of major depression

NEW YORK, N.Y., Aug. 15, 2002 -- Forest Laboratories announced that Lexapro (escitalopram oxalate), a powerful, effective and well-tolerated selective serotonin reuptake inhibitor, has been approved by the FDA for the treatment of major depressive disorder.

Forest expects Lexapro to be available in pharmacies by September 5.

"There is a definite need for newer therapies that specifically address the critical issues that most interfere with the treatment of depression, including low response to medications and intolerable side effects," said Jack M. Gorman, M.D., Lieber Professor and Vice Chair for Research of the Department of Psychiatry at the College of Physicians and Surgeons, Columbia University.

"Lexapro is a welcomed treatment option because it offers many patients relief from depression symptoms quickly, with few side effects and a low risk of drug interactions."

Lexapro's efficacy and tolerability have been demonstrated in clinical trials. The recommended dose of Lexapro is 10 mg daily, which was comparable in a clinical trial to the higher titrated dose of Celexa at 40 mg daily. Additionally, many patients taking Lexapro 10 mg per day demonstrated a significant improvement in depressive symptoms beginning after the first or second week of treatment.

"While Celexa, which Forest first introduced in 1998, is still the fastest growing SSRI in the market and has proven effective in the treatment of major depression, Lexapro's combination of tolerability and powerful efficacy, resulting in many patients experiencing relief early in their treatment, may make it highly desirable for the treatment of major depression," said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories.

Clinical trials

Lexapro's approval was based on efficacy and safety data from clinical trials involving more than 1,100 patients, including men and women ages 18-65 with moderate and severe depression.

In a double-blind, placebo-controlled, multicenter study, 491 patients with an ongoing major depressive episode 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. Lexapro at 10 mg per day and 20 mg per day demonstrated significantly greater improvement relative to placebo (p less than or equal to 0.01).

Additionally, Lexapro 10 mg was shown to be as effective as 40 mg of Celexa on the major efficacy outcome variables. The Montgomery Asberg Depression Rating Scale (MADRS), which was the prospectively defined primary endpoint, showed that patients taking Lexapro 10 or 20 mg per day significantly improved relative to patients taking placebo beginning at week two and maintained that separation at all time points. Secondary endpoint measures, including the Hamilton Depression Rating Scale (HAM-D), the HAM-D mood item, and Clinical Global Impression of Improvement (CGI-I), showed that Lexapro 10 and 20 mg per day statistically separated from placebo at either week one or two, while Celexa separated later.

In a pooled analysis of three eight-week studies of Lexapro, Celexa, and placebo in patients with major depressive disorder, researchers found that Lexapro was statistically superior to placebo in all common efficacy measures, including MADRS and CGI-I, beginning at week one and continuing throughout the study period.

Lexapro was well tolerated at doses of 10 and 20 mg per day. Lexapro dropout rates due to adverse events and the overall incidence of side effects for the 10 mg daily dose were comparable to placebo in the studies. In the comprehensive safety database for Lexapro, only one adverse event, nausea (15% for Lexapro-treated patients vs. 7% for placebo-treated patients), occurred in more than 10% of patients.

The most common adverse events reported with Lexapro vs. placebo (occurring >5% and approximately twice the incidence of placebo) were nausea (15% vs. 7%), insomnia (9% vs. 4%), ejaculation disorder (9% vs. <1%), somnolence (6% vs. 2%), sweating increased (5% vs. 2%) and fatigue (5% vs. 2%).

An isomer of Celexa

Lexapro is the product of a relatively new approach that involves the removal of one of two enantiomers from Celexa to create a single-enantiomer drug. Celexa is a racemic mixture of two mirror-image halves called the S- and R-enantiomers. With Lexapro, the R-enantiomer (that does not contribute to Celexa's antidepressant activity) has been removed, leaving only the therapeutically active S-enantiomer.

Forest Laboratories licensed Lexapro from the Danish pharmaceutical firm H. Lundbeck A/S, which developed both citalopram and escitalopram in Europe. Escitalopram is currently approved for marketing in several European countries, including Sweden, Switzerland, Denmark, Belgium, Great Britain, France, Ireland, and Austria, under the name Cipralex.

Posted: August 2002


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