NEW YORK, Dec. 2 /PRNewswire-FirstCall/ -- Forest Laboratories Inc.
(NYSE: FRX) announced today that the U.S. Food and Drug Administration
approved for marketing an oral solution of Lexapro(TM) (escitalopram oxalate).
Lexapro, a selective serotonin reuptake inhibitor (SSRI), is the single isomer
of Celexa(TM) (citalopram HBr). Lexapro was approved in August 2002 by the FDA
for the treatment of major depressive disorder and maintenance treatment. The
oral solution of Lexapro will be available commercially by first quarter 2003
and will provide an added convenience and ease of use for certain patients.
The New Drug Application (NDA) for the oral solution was submitted on
November 2, 2001. Like the tablet formulation, the oral solution of Lexapro
is a safe and effective treatment for major depressive disorder. In clinical
trials, many patients taking Lexapro 10 mg per day demonstrated a significant
improvement in depressive symptoms beginning at the first or second week of
treatment. Additionally, 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. Lexapro also has a low risk of drug-drug
interactions. The most common adverse events reported with Lexapro were
nausea, insomnia, ejaculation disorder, somnolence, sweating increased and
fatigue.
Due to the ease of administration, Lexapro oral solution will provide
treatment benefits to a wider range of patients, including the elderly and
others who have difficulty swallowing tablets.
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 period ended June 30, 2002 and September 30,
2002. Actual results may differ materially from those projected.
*Benicar is a registered trademark of Sankyo Pharma.