FDA Approves Lexapro
Lexapro, The Single-Isomer of Celexa, Receives FDA Approval For the Treatment of Major Depression
NEW YORK, Aug 15, 2002 /PRNewswire-FirstCall via COMTEX/ -- Forest Laboratories, Inc., (NYSE: FRX) announced today that Lexapro (escitalopram oxalate), a powerful, effective and well-tolerated selective serotonin reuptake inhibitor (SSRI), has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder. Forest expects Lexapro to be available in pharmacies by September 5th.
"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.
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%).
Each year, nearly 19 million adult Americans suffer from a depressive illness. One of every 4 women and 1 in 10 men can expect to be diagnosed with depression during their lifetime. Depression costs the United States an estimated $44 billion each year. The World Health Organization predicts depression will become the leading cause of disability by the year 2020.
About Lexapro: 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.
About Forest Laboratories and Its Products
Forest Laboratories develops, manufactures, and sells ethical pharmaceutical products that are used for the treatment of a wide range of illnesses. Forest's growing line of products includes: Celexa, which has been prescribed for more than eight million U.S. patients and is the fastest growing antidepressant in the U.S.; Tiazac(R), a once-daily diltiazem, which is indicated for the treatment of angina and hypertension; and Aerobid(R) an inhaled steroid indicated for the treatment of asthma. The Company has also entered into a co-promotion agreement with Sankyo of Japan for the marketing of Benicar* for the treatment of hypertension.
Forest is also developing a growing portfolio of pharmaceutical products, which includes: Aerospan(R) (flunisolide) for the treatment of asthma, memantine for Alzheimer's disease and neuropathic pain, lercanidipine for hypertension, acamprosate for the treatment of alcohol dependence, a combination of oxycodone and ibuprofen for the treatment of moderate to severe pain, dexloxiglumide for irritable bowel syndrome, and neramexane for various central nervous system disorders.
Full prescribing information is available upon request.
Except for historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2002 and Quarterly Report on Form 10-Q for the period ended June 30, 2002. Actual results may differ materially from those projected.
*Benicar is a registered trademark of Sankyo Pharma.
Posted: August 2002
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