NEW YORK, May 1, 2003 /PRNewswire-FirstCall via COMTEX/ -- 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
panic disorder. Lexapro is the newest and most selective serotonin reuptake
inhibitor (SSRI) indicated for the initial and maintenance treatment of major
depressive disorder.
About Panic Disorder
The prevalence of panic disorder is estimated to be 2.4 million people or
1.7% 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 panic disorder is the presence of
recurrent unexplained panic attacks followed by one month of persistent
concern about having another panic attack, worry about the possible
implications or consequences of the panic attacks, or a significant behavioral
change related to the attacks. Panic attacks are brief episodes of intense
fear accompanied by multiple physical symptoms. Panic disorder can occur with
other anxiety disorders, depressive disorders, or substance abuse.
About Lexapro
Lexapro(TM) (escitalopram oxalate) is the newest and fastest-growing
selective serotonin reuptake inhibitor (SSRI). Lexapro was developed by
isolating the therapeutically active portion of the antidepressant Celexa(TM)
(citalopram HBr).
Lexapro was approved by the U.S. Food and Drug Administration (FDA) in
August 2002 for both the initial and maintenance treatment of major depressive
disorder. Lexapro is available as tablets and oral solution.
In clinical trials, the most common side effects reported with Lexapro
versus placebo were nausea, insomnia, problems with ejaculation, somnolence,
increased sweating, and fatigue. As with all SSRIs, Lexapro should not be
taken together with monoamine oxidase inhibitors (MAOI). Full prescribing
information is available at www.lexapro.com.
Forest Laboratories licenses Lexapro from the Danish pharmaceutical firm
H. Lundbeck A/S, which developed escitalopram and citalopram. In Europe,
escitalopram is marketed under the name Cipralex(R).
About Forest Laboratories and Its Products
Forest Laboratories develops, manufactures, and sells pharmaceutical
products that are used for the treatment of a wide range of illnesses. Forest
Laboratories' growing line of products includes: Lexapro(TM), indicated for
the initial and maintenance treatment of major depressive disorder;
Celexa(TM), an antidepressant; Tiazac(R), a once-daily diltiazem, indicated
for the treatment of angina and hypertension; Benicar(R)*, an angiotensin
receptor blocker indicated for the treatment of hypertension; and Aerobid(R),
an inhaled steroid indicated for the treatment of asthma.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities 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 ending June 30, 2002, September 30, 2002
and December 31, 2002. Actual results may differ materially from those
projected.
*Benicar is a registered trademark of Sankyo Pharma, Inc.