NEW YORK, Dec. 10 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today the results of a clinical study, which showed that
Lexapro(TM) (escitalopram oxalate) is as effective and well tolerated as
Zoloft(R) (sertraline hydrochloride). The purpose of the study was to
evaluate whether the starting dose of Lexapro, 10 mg per day, could provide
comparable efficacy to the full dosing range of Zoloft, 50 - 200 mg per day.
Study results showed that patients receiving a dose of 10 mg per day of
Lexapro experienced similar efficacy compared to patients receiving a median
dose of Zoloft of 150 mg per day. At week four, 46 percent of Zoloft-treated
patients received 150 mg per day or higher, and at week eight, 65 percent
received 150 mg per day or higher. To achieve a dose of 150 mg per day or
higher, patients treated with Zoloft required at least two dose titrations.
Both Lexapro and Zoloft belong to a class of antidepressants known as
selective serotonin reuptake inhibitors (SSRIs). The study was presented in
Puerto Rico at an annual meeting of neuropsychopharmacologists.
"In this study, most patients experienced relief from depressive symptoms.
Patients treated with Lexapro received 10 mg throughout the study period,
while patients treated with Zoloft received dosages based on depressive
symptoms and the development of side effects," said George Alexopoulos, M.D.,
Professor of Psychiatry at Weill Medical College of Cornell University.
"Lexapro is an effective treatment for depression with simple dosing that may
improve patient adherence."
Each year, nearly 19 million adult Americans suffer from mild, moderate,
or severe depression. One in 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.
Study Conclusions
Lexapro and Zoloft demonstrated comparable efficacy in reducing symptoms
of depression and anxiety in patients with major depressive disorder. At week
eight of the study, 75 percent of Lexapro-treated patients and 70 percent of
Zoloft-treated patients were considered responders, meaning they achieved a 50
percent or better reduction from baseline in their Montgomery-Asberg
Depression Rating Scale (MADRS) scores. Mean changes in MADRS scores from
baseline to endpoint were -19.1 and -18.4 for the Lexapro and Zoloft groups,
respectively. For patients who were severely depressed at baseline (MADRS
score greater than or equal to 30; N=92), mean changes in MADRS scores from
baseline to endpoint were -22.4 and -20.4 for the Lexapro and Zoloft groups,
respectively. Patients treated with Lexapro and Zoloft each experienced
improvement in anxiety symptoms associated with depression, according to the
Hamilton Rating Scale for Depression (HAM-D) Anxiety Subscale total score.
Both Lexapro and Zoloft were well tolerated in the eight-week study.
Overall, about 85 percent of patients in each group completed the study. Only
two and four percent of patients discontinued due to adverse events with
Lexapro and Zoloft, respectively. Adverse events occurring at an incidence of
greater than or equal to 10 percent with Lexapro or Zoloft, respectively,
included ejaculation disorder (23% and 23%), diarrhea (13% and 23%), nausea
(17% and 17%), insomnia (14% and 17%), libido decreased (10% and 14%), upper
respiratory tract infection (10% and 14%), dry mouth (4% and 14%), headache
(13% and 10%), and somnolence (12% and 6%).
Study Methodology
Two hundred twelve patients, 18 to 80 years of age with major depressive
disorder (baseline MADRS score greater than or equal to 22), participated in
the double-blind study. Following a one-week, single-blind, placebo lead-in
period, patients were randomized to receive either a fixed dose of 10 mg per
day of Lexapro (N=104) or a flexible dose of 50 to 200 mg per day of Zoloft
(N=108). If clinically indicated, Zoloft was increased in 50 mg increments
each week, as recommended in the U.S. package insert. The dose could also be
decreased due to tolerability concerns. The mean dose of Zoloft at week eight
was 144 mg per day. The primary efficacy variable was the change in the MADRS
total score from baseline to week eight. The HAM-D Anxiety Subscale was also
administered at each visit.
About Lexapro
Lexapro is the newest and fastest-growing selective serotonin reuptake
inhibitor (SSRI) and is prescribed for more than three million patients in the
U.S. 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.
As with all SSRIs, Lexapro should not be taken with monoamine oxidase
inhibitors (MAOI). For more information about Lexapro, please visit
www.lexapro.com.
Forest Laboratories licenses Lexapro from H. Lundbeck A/S, the Danish
pharmaceutical firm that developed escitalopram and citalopram.
About Forest Laboratories and Its Products
Forest Laboratories'growing line of products includes: Lexapro(TM),
indicated for the initial and maintenance treatment of major depressive
disorder; Celexa(TM), an antidepressant; Namenda(TM), an N-methyl D-aspartate
(NMDA) receptor antagonist indicated for the treatment of moderate to severe
Alzheimer's disease; 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; Benicar HCT(TM)*, an
angiotensin receptor blocker and diuretic combination product indicated for
the second-line treatment of hypertension; and Aerobid(R), an inhaled steroid
indicated for the treatment of asthma.
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, 2003, and Quarterly
Reports on Form 10-Q for the periods ending June 30, 2003, and September 30,
2003. Actual results may differ materially from those projected.
* Benicar(R) and Benicar HCT(TM) are registered trademarks of Sankyo
Pharma, Inc.