FDA Approves Lexapro as Maintenance Treatment for Major Depressive Disorder
Lexapro Approved as Maintenance Treatment for Major Depressive Disorder
NEW YORK, Aug 29, 2002 /PRNewswire-FirstCall via COMTEX/ -- Forest Laboratories, Inc. (NYSE: FRX) announced today that the U.S. Food and Drug Administration (FDA) has approved new labeling for Lexapro (escitalopram oxalate) as maintenance treatment for patients with major depressive disorder. Lexapro, a selective serotonin reuptake inhibitor (SSRI), is the single-isomer of Celexa (citalopram HBr).
The long-term efficacy of Lexapro was demonstrated in a placebo-controlled relapse trial. Patients receiving Lexapro experienced a significantly longer time to relapse compared to those receiving placebo. Relapse in depression is defined as the return of the symptoms of depression within four to six months of achieving initial success with antidepressant treatment. Lexapro was approved by the FDA on August 14, 2002 for the treatment of major depressive disorder.
"We are pleased that the FDA has granted Lexapro this additional indication shortly after its approval of Lexapro for the treatment of major depressive disorder," said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories. "Relapse is one of the greatest concerns following successful treatment of depression. The use of Lexapro as maintenance therapy may help people who suffer from depression lead more productive lives."
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. For more information on Lexapro, visit http://www.lexapro.com.
Forest Laboratories licensed Lexapro from the Danish pharmaceutical firm H. Lundbeck A/S, which developed both citalopram and escitalopram in Europe.
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: Lexapro, indicated as initial as well as maintenance treatment of major depressive disorder; Celexa, indicated for the treatment of depression; 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.
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.
Posted: August 2002
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