NEW YORK, Nov. 27 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that it has submitted a supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration to expand the
labeling of Lexapro(TM) (escitalopram oxalate) to include the treatment of
generalized anxiety disorder (GAD). The sNDA is based on three
placebo-controlled studies in patients suffering from GAD. Lexapro, the
single-isomer of Celexa(TM) (citalopram HBr), is a newly approved selective
serotonin reuptake inhibitor (SSRI) for the initial and maintenance treatment
of major depressive disorder.
About Generalized Anxiety Disorder
Anxiety disorders are the most common mental illness in the U.S.,
affecting 19.1 million adults, and they cost the U.S. more than $42 billion a
year. The prevalence of generalized anxiety disorder (GAD) is estimated to be
4 million or 2.8% of the U.S. population, and it affects women twice as often
as men. According to The Diagnostic and Statistical Manual of Mental
Disorders (DSM-IV-TR), the essential feature of GAD is excessive anxiety and
worry (apprehensive expectations) about every day events or activities for a
period of six months or more. This constant worry affects daily functioning
and can cause physical symptoms. For a diagnosis to be made, worry must be
present more days than not for at least six months. GAD frequently co-occurs
with mood disorders, including depression. Additionally, up to 80% of people
suffering from depression also experience symptoms of anxiety.
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(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
Reports on Form 10-Q for the periods ended June 30, 2002 and September 30,
2002. Actual results may differ materially from those projected.
*Benicar is a registered trademark of Sankyo Pharma.