NEW YORK, Dec. 11 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced the results of a pooled analysis of three positive
generalized anxiety disorder (GAD) studies involving Lexapro(TM) (escitalopram
oxalate) at an annual meeting of neuropsychopharmacologists. Additionally,
one of the studies included in the pooled analysis was presented separately
during the meeting. Each of the data sets showed patients receiving Lexapro
had significantly greater improvement in anxiety symptoms relative to placebo
beginning at the end of week one and continuing through the end of week eight.
"Currently, more than four million Americans suffer from generalized
anxiety disorder," said Jonathan Davidson, M.D., Professor of Psychiatry,
Director of the Anxiety and Traumatic Stress Program at Duke University. "For
this reason, physicians are actively seeking new medications for the treatment
of anxiety."
GAD Pooled Analysis
More than 800 GAD patients participated in the three double blind,
placebo-controlled, multi-center, eight-week studies. All three GAD studies
were virtually identical in design, where the dose of Lexapro was fixed at 10
mg per day for the first four weeks and then flexibly dosed from 10-20 mg per
day.
The primary efficacy variable was the HAMA total score. The HAMA psychic
anxiety subscale, the CGI-I and the CGI-Severity were secondary efficacy
variables. Analyses of the primary and secondary efficacy variables revealed
significantly greater improvement in the Lexapro group relative to placebo
beginning at the end of week one and continuing through the end of the study.
Lexapro was well tolerated by patients in the study with low rates of
adverse events. The most common adverse events reported were headache,
ejaculation disorder, nausea, diarrhea, and insomnia.
GAD Placebo-Controlled Study
One of the studies included the pooled analysis involved three hundred
fifteen patients, aged 18 years and older, with GAD. Patients were randomly
assigned to double-blind treatment with Lexapro (10 mg per day for the first
four weeks, then flexibly dosed from 10-20 mg per day) or placebo for eight
weeks. Patients treated with Lexapro showed a significantly greater
improvement at endpoint compared with placebo in all prospectively defined
efficacy parameters, including the Hamilton Rating Scale for Anxiety (HAMA),
the Clinical Global Impressions (CGI) scores, the Hospital Anxiety and
Depression (HAD) scale, the Covi and Raskin scales and the Quality of Life
(QOL) scale.
In addition, treatment with Lexapro was well tolerated, with low rates of
reported adverse events and an incidence of discontinuation due to adverse
events not statistically different from placebo (8.9 percent vs. 5.1 percent).
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 is estimated to be 4
million or 2.8 percent of the U.S. population, and it affects women twice as
often as men. According to 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 percent 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(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 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.