NEW YORK, Dec 18, 2003 /PRNewswire-FirstCall via Comtex/ -- Forest Laboratories, Inc.
(NYSE: FRX) 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.
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
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.