Contact: Charles E. Triano 212-224-6714 Forest Laboratories NEW
YORK,(USA) - Forest Laboratories, Inc. (NYSE:FRX) announced today
that the U.S. Food and Drug Administration (FDA) have agreed
Lexapro (escitalopram oxalate), a selective
serotonin reuptake inhibitor (SSRI), in favour of the
attention of generalized anxiety
lawlessness (GAD), a rider that affect more or less four million
Americans annually.
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greater systolic blood tension (SBP) than women could be because
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girls of one and duplicate age.
Lexapro is also indicate for the opening treatment and upholding
of focal depressive disorder.
'One of the biggest challenge in treat GAD patients is finding a
treatment to be precise not merely strong-willed, but also one
that patients will be capable of tummy for the prolonged
tenancy,' said Philip Ninan, M.D., professor of Psychiatry and
Behavioral Sciences and administrator of the Mood and Anxiety
Disorders Program at Emory University School of Medicine.
'Lexapro is a first-line treatment choice, which has proven to be
effective effective a favorable on the side effect profile.'
Study Details All three studies that support the indication
authorization were randomized, double-blind, eight weeks in
duration and placebo-controlled. The studies various uphill
approximately 850 patients, 18 to 80 years of age, diagnose with
GAD.
Patients in the Lexapro arm were administered a parallel dose of
10 mg per daylight for the first night four weeks and after
flexibly dose to a maximum of 20 mg per day.
The Hamilton Anxiety Scale (HAMA) whole evaluation be the initial
efficacy fitful, and lower efficacy measures built-in transfer in
HAMA medium anxiety subscale and
Clinical Global Impressions (CGI) score.
In each of the three studies, Lexapro 10 to 20 mg per day
significantly superior GAD symptom in patients associate to
placebo by vehicle of measured by change from baseline in HAMA
score.
By-visit analyses of scandal pooled across the three studies
revealed significantly greater progress in the Lexapro degree
starting point at week one or two and continuing through week
eight for all primary and secondary efficacy variables.
For further update, name and information on Symbicort, indulge
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Budesonide/formoterol as maintenance and reliever therapy reduces
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exacerbations versus a higher maintenance dose of
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Abstract presented at the ERS Congress 2006.
Sixty-eight percent of Lexapro-treated patients in the study
demonstrated a significant rejoinder rate as compared to 41
percent of placebo-treated patients. In insertion, higher than
twofold as heaps 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 economically tolerate in the pooled analysis of the
three studies, with eight percent of patients discontinue
treatment in the red to adverse measures compared to four percent
of patients in the placebo group.
The greatest prevalently report 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%), decrease libido (6.8% vs. 2.1%)
and anorgasmia (5.7% vs. 0.4%).
About Generalized Anxiety Disorder Anxiety disorder be the most
customary passionate virus in the U.S., affecting 19.1 million
adults, and damage the U.S. more than $42 billion a year.
The significant symbols of generalized anxiety disorder (GAD) is
ballpark to be four million or 2.8% of the U.S. population, and
it affects women mega regularly as man. According to The
Diagnostic and Statistical Manual of Mental Disorders
(DSM-IV-TR), the broad portion of GAD is excessive anxiety and
worry (apprehensive expectations) almost homespun events or
goings-on for a length of six months or more.
This inestimable worry affects daily functioning and can proceed
in corporal symptoms. For a diagnosis to be made, worry must be
existing more days than not for at lowest six months. GAD over
and done with and over again co-occurs with bias disorders, with
sheer. Additionally, capable of 80% of contacts burden from
depression also
submit yourself to symptoms of anxiety.
About Lexapro Lexapro is the most up-to-date 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 reachable as
tablets and oral medication.
As with all SSRIs, Lexapro should not be taken with monoamine
oxidase inhibitors (MAOI). For more information about Lexapro,
indulge impede by Forest Laboratories license Lexapro from H.
Lundbeck A/S, the Danish pharmaceutical stubborn that modern
escitalopram and citalopram.
About Forest Laboratories and Its Products Forest
Laboratories'growing crash of products include: Lexapro,
indicated for the initial and maintenance treatment of major
depressive disorder; Celexa, an antidepressant; Namenda, an
N-methyl D-aspartate (NMDA) receptor antagonist indicated for the
treatment of moderate to sober Alzheimer's disease; Tiazac, a
once-daily diltiazem, indicated for the treatment of angina and
hypertension; Benicar*, an angiotensin receptor blocker indicated
for the treatment of hypertension; Benicar HCT*, an angiotensin
receptor blocker and diuretic assortment service indicated for
the second-line treatment of hypertension; and Aerobid, an inhale
steroid indicated for the treatment of asthma.
Except for historical information contained herein, this freedom
contain 'forward-looking statements' inwardly the description of
the Private Securities Litigation Reform Act of 1995. These
statement are clash to hazard and uncertainties that affect our
company, including risk factor down from taking place to time in
the Company's SEC reports, including the Company's Annual Report
on Form 10-K for the fiscal year terminated March 31, 2003, and
Quarterly Reports on Form 10-Q for the period culmination June
30, 2003, and September 30, 2003. Actual grades may fluctuate
materially from those projected.
* Benicar and Benicar HCT are list trademark of Sankyo Pharma,
Inc.
