NEW YORK, Sep 5, 2002 /PRNewswire-FirstCall via COMTEX/ -- Forest Laboratories
Inc. (NYSE: FRX) announced today the commencement of an 8-week, open-label
clinical trial called EXCEED (EXamining Clinical Experience with Escitalopram in
Depression) to gain knowledge about the use of Lexapro(TM) (escitalopram
oxalate) in a standard clinical practice setting. The goal of the trial is to
enroll several thousand patients throughout the U.S. and assess the effect of
Lexapro treatment on the quality of life of patients with major depressive
disorder.
"Lexapro's efficacy and tolerability have been well established in numerous
clinical trials, and the next logical step is to evaluate its effect on quality
of life," said Larry Culpepper, MD, MPH Chairman, Department of Family Medicine,
Boston University Medical School and EXCEED Trial Advisor. "The EXCEED trial
will provide invaluable information to the medical community about the use of
Lexapro in standard U.S. clinical practice."
Patients are eligible for enrollment if they are 18 years of age or older, have
been diagnosed with major depressive disorder by their physicians and provide
informed consent to participate in the trial. The EXCEED trial has four
exclusion criteria: pregnant or nursing, use of a monoamine oxidase inhibitor
(MAOI) within the last two weeks, hypersensitivity reaction to
citalopram/escitalopram, and drug abuse.
About Depression
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(TM)
Lexapro is the product of a relatively new approach that involves the removal of
one of two enantiomers from Celexa(TM) (citalopram HBr) 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(TM), indicated as initial as well as
maintenance treatment of major depressive disorder; Celexa(TM), 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(TM)* 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.