NEW YORK, Aug 15, 2002 /PRNewswire-FirstCall via COMTEX/ -- Forest
Laboratories, Inc., (NYSE: FRX) announced today that Lexapro(TM) (escitalopram
oxalate), a powerful, effective and well-tolerated selective serotonin reuptake
inhibitor (SSRI), has been approved by the U.S. Food and Drug Administration
(FDA) for the treatment of major depressive disorder. Forest expects Lexapro to
be available in pharmacies by September 5th.
"There is a definite need for newer therapies that specifically address the
critical issues that most interfere with the treatment of depression, including
low response to medications and intolerable side effects," said Jack M. Gorman,
M.D., Lieber Professor and Vice Chair for Research of the Department of
Psychiatry at the College of Physicians and Surgeons, Columbia University.
"Lexapro is a welcomed treatment option because it offers many patients relief
from depression symptoms quickly, with few side effects and a low risk of drug
interactions."
Lexapro's efficacy and tolerability have been demonstrated in clinical trials.
The recommended dose of Lexapro is 10 mg daily, which was comparable in a
clinical trial to the higher titrated dose of Celexa at 40 mg daily.
Additionally, many patients taking Lexapro 10 mg per day demonstrated a
significant improvement in depressive symptoms beginning after the first or
second week of treatment.
"While Celexa, which Forest first introduced in 1998, is still the fastest
growing SSRI in the market and has proven effective in the treatment of major
depression, Lexapro's combination of tolerability and powerful efficacy,
resulting in many patients experiencing relief early in their treatment, may
make it highly desirable for the treatment of major depression," said Howard
Solomon, Chairman and Chief Executive Officer of Forest Laboratories.
Clinical Trials
Lexapro's approval was based on efficacy and safety data from clinical trials
involving more than 1,100 patients, including men and women ages 18-65 with
moderate and severe depression.
In a double-blind, placebo-controlled, multicenter study, 491 patients with an
ongoing major depressive episode were randomized for eight weeks to one of four
trial arms: placebo, Lexapro at 10 mg per day, Lexapro at 20 mg per day, or
Celexa at 40 mg per day. Lexapro at 10 mg per day and 20 mg per day demonstrated
significantly greater improvement relative to placebo (p less than or equal to
0.01). Additionally, Lexapro 10 mg was shown to be as effective as 40 mg of
Celexa on the major efficacy outcome variables. The Montgomery Asberg Depression
Rating Scale (MADRS), which was the prospectively defined primary endpoint,
showed that patients taking Lexapro 10 or 20 mg per day significantly improved
relative to patients taking placebo beginning at week two and maintained that
separation at all time points. Secondary endpoint measures, including the
Hamilton Depression Rating Scale (HAM-D), the HAM-D mood item, and Clinical
Global Impression of Improvement (CGI-I), showed that Lexapro 10 and 20 mg per
day statistically separated from placebo at either week one or two, while Celexa
separated later.
In a pooled analysis of three eight-week studies of Lexapro, Celexa, and placebo
in patients with major depressive disorder, researchers found that Lexapro was
statistically superior to placebo in all common efficacy measures, including
MADRS and CGI-I, beginning at week one and continuing throughout the study
period.
Lexapro was well tolerated at doses of 10 and 20 mg per day. 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. In the comprehensive
safety database for Lexapro, only one adverse event, nausea (15% for
Lexapro-treated patients vs. 7% for placebo-treated patients), occurred in more
than 10% of patients. The most common adverse events reported with LEXAPRO vs.
placebo (occurring >5% and approximately twice the incidence of placebo) were
nausea (15% vs. 7%), insomnia (9% vs. 4%), ejaculation disorder (9% vs. <1%),
somnolence (6% vs. 2%), sweating increased (5% vs. 2%) and fatigue (5% vs. 2%).
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
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.
Forest Laboratories licensed Lexapro from the Danish pharmaceutical firm H.
Lundbeck A/S, which developed both citalopram and escitalopram in Europe.
Escitalopram is currently approved for marketing in several European countries,
including Sweden, Switzerland, Denmark, Belgium, Great Britain, France, Ireland,
and Austria, under the name Cipralex.
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: Celexa, which has been prescribed for more
than eight million U.S. patients and is the fastest growing antidepressant in
the U.S.; 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.
Forest is also developing a growing portfolio of pharmaceutical products, which
includes: Aerospan(R) (flunisolide) for the treatment of asthma, memantine for
Alzheimer's disease and neuropathic pain, lercanidipine for hypertension,
acamprosate for the treatment of alcohol dependence, a combination of oxycodone
and ibuprofen for the treatment of moderate to severe pain, dexloxiglumide for
irritable bowel syndrome, and neramexane for various central nervous system
disorders.
Full prescribing information is available upon request.
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.
*Benicar is a registered trademark of Sankyo Pharma.