Lexapro(TM) Receives FDA Approval for the Treatment of Generalized Anxiety Disorder
December 18 2003 - 3:46PM
PR Newswire (US)
Lexapro(TM) Receives FDA Approval for the Treatment of Generalized
Anxiety Disorder NEW YORK, Dec. 18 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc. announced today that the U.S. Food and Drug
Administration (FDA) has approved Lexapro(TM) (escitalopram
oxalate), a selective serotonin reuptake inhibitor (SSRI), for the
treatment of generalized anxiety disorder (GAD), a condition that
affects approximately four million Americans annually. The new
indication is based on three studies, all of which were positive
and support the efficacy and safety of Lexapro in the treatment of
GAD. GAD is characterized by excessive anxiety and worry that
significantly impacts an individual's daily functioning. Lexapro is
also indicated for the initial treatment and maintenance of major
depressive disorder. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO Photo:
http://www.newscom.com/cgi-bin/prnh/20031218/LEXAPRO ) "One of the
biggest challenges in treating GAD patients is finding a treatment
that is not only effective, but also one that patients will be able
to tolerate for the long term," said Philip Ninan, M.D., professor
of Psychiatry and Behavioral Sciences and director of the Mood and
Anxiety Disorders Program at Emory University School of Medicine.
"Lexapro is a first-line treatment option, which has proven to be
effective with a favorable side effect profile." Study Details All
three studies that support the indication approval were randomized,
double-blind, eight weeks in duration and placebo-controlled. The
studies involved approximately 850 patients, 18 to 80 years of age,
diagnosed with GAD. Patients in the Lexapro arm were administered a
fixed dose of 10 mg per day for the first four weeks and then
flexibly dosed to a maximum of 20 mg per day. The Hamilton Anxiety
Scale (HAMA) total score was the primary efficacy variable, and
secondary efficacy measures included changes in HAMA psychic
anxiety subscale and Clinical Global Impressions (CGI) scores. In
each of the three studies, Lexapro 10 to 20 mg per day
significantly improved GAD symptoms in patients compared to placebo
as measured by change from baseline in HAMA score. By-visit
analyses of data pooled across the three studies revealed
significantly greater improvement in the Lexapro group beginning at
week one or two and continuing through week eight for all primary
and secondary efficacy variables. Further analysis of one of the
three placebo-controlled studies showed that Lexapro-treated
patients experienced a significant improvement in quality of life
compared to patients treated with placebo as measured by the
Quality of Life (QOL) scale. Sixty-eight percent of Lexapro-treated
patients in the study demonstrated a significant response rate as
compared to 41 percent of placebo-treated patients. In addition,
more than twice as many patients in the Lexapro 10 to 20 mg per day
group were in remission at week eight than in the placebo group, 36
and 16 percent, respectively. Lexapro was well tolerated in the
pooled analysis of the three studies, with eight percent of
patients discontinuing treatment due to adverse events compared to
four percent of patients in the placebo group. The most commonly
reported adverse events in the Lexapro group versus placebo were
nausea (18.2% vs. 7.5 %), ejaculation disorder (14.3% vs. 1.5%),
insomnia (11.9% vs. 5.6%), fatigue (7.7% vs. 2.1%), decreased
libido (6.8% vs. 2.1%) and anorgasmia (5.7% vs. 0.4%). About
Generalized Anxiety Disorder Anxiety disorders are the most common
mental illness in the U.S., affecting 19.1 million adults, and cost
the U.S. more than $42 billion a year. The prevalence of
generalized anxiety disorder (GAD) is estimated to be four million
or 2.8% 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 GAD is
excessive anxiety and worry (apprehensive expectations) about
everyday 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% of people suffering from depression also experience
symptoms of anxiety. About Lexapro Lexapro is the newest and
fastest-growing selective serotonin reuptake inhibitor (SSRI) and
is prescribed for more than four million patients in the U.S.
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 http://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.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://www.newscom.com/cgi-bin/prnh/20031218/LEXAPRO DATASOURCE:
Forest Laboratories, Inc. CONTACT: Charles E. Triano, Vice
President - Investor Relations of Forest Laboratories, Inc.,
+1-212-224-6714, or Web site: http://www.frx.com/
http://www.lexapro.com/
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