Three New Studies Presented at Anxiety Disorders Association of America's Annual Meeting
NEW YORK, Mar 20, 2002 /PRNewswire-FirstCall via COMTEX/ -- Forest
Laboratories, Inc. (NYSE: FRX) announced that clinical study results were
presented today at the annual meeting of the Anxiety Disorders Association of
America (ADAA), including a trial demonstrating that Lexapro(TM) (escitalopram
oxalate) significantly reduced anxiety in patients with generalized anxiety
disorder (GAD) when compared to placebo. Other research presented at the meeting
included a study demonstrating that, when compared to placebo, Lexapro
significantly reduced panic symptoms in patients with panic disorder, including
panic attack frequency and severity, and a study showing that Lexapro
significantly improved symptoms in patients with social anxiety disorder (SAD)
as compared to placebo. Lexapro, the single-active isomer of Celexa(TM)
(citalopram HBr), is an investigational selective serotonin reuptake inhibitor
(SSRI).
Forest submitted a new drug application to the Food and Drug Administration
(FDA) in March, 2001, requesting approval to market Lexapro as a treatment for
major depressive disorder, and Forest recently received an approvable letter
from the FDA. Forest expects that the launch of Lexapro as a treatment for major
depressive disorder, which is still subject to final FDA approval, will occur in
mid-2002. In addition, the data presented at the ADAA meeting on generalized
anxiety disorder, panic disorder and social anxiety disorder may be used to seek
future indications.
Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories,
said, "In addition to our submission for major depressive disorder, Forest is
committed to investigating Lexapro's full potential, and the studies presented
at ADAA are extremely encouraging."
Lexapro and Generalized Anxiety Disorder
At the ADAA meeting, Duke University researchers presented clinical study
results that showed Lexapro significantly reduced anxiety symptoms in patients
with generalized anxiety disorder when compared to placebo. In the double-blind,
placebo-controlled study, 240 patients with GAD were randomized to two treatment
arms: placebo group or a Lexapro flexible-dose group for eight weeks following a
one-week, single-blind placebo lead-in period. Patients were 18 to 80 years of
age.
Lexapro significantly improved anxiety symptoms relative to placebo treatment,
as measured by the primary evaluation tool, Hamilton Anxiety Scale (HAMA).
Secondary evaluation tools, which also showed significant improvement by
Lexapro, included the Clinical Global Impressions Scale (CGI), the Hospital
Anxiety Depression Scale (HAD), and the Quality of Life Questionnaire. Patients
treated with Lexapro also reported their quality of life had significantly
improved. In the study, Lexapro was well tolerated; the most common adverse
events reported in Lexapro patients were headache, nausea and insomnia.
GAD is characterized by excessive anxiety and worry (apprehensive expectation),
occurring more days than not for at least six months, about various events or
activities such as work or school performance.
Lexapro and Panic Disorder
Researchers from the University of California, San Diego, presented study
results at the ADAA meeting that showed that, when compared to placebo, Lexapro
significantly reduced panic disorder symptoms such as panic attack frequency and
severity as well as anticipatory anxiety and phobic avoidance.
In the randomized, double-blind, placebo-controlled, multicenter study, 247
patients received either placebo or a flexible-dose of Lexapro for 10 weeks
following a two-week, single-blind, placebo lead-in period. Study participants,
ranging in age from 18 to 80 years old, had been diagnosed with panic disorder
with or without agoraphobia (anxiety about being in places or situations from
which escape might be difficult or embarrassing).
Additionally, Lexapro-treated patients experienced a significant improvement in
their overall status and quality of life as measured by the Modified Sheehan
Panic and Anticipatory Anxiety Scale, the Panic and Agoraphobia Scale, the
Hamilton Anxiety Scale, Clinical and Global Impressions Scale, Patient Global
Evaluation, and the Quality of Life Questionnaire. In the study, Lexapro was
well tolerated; the rate of discontinuation due to adverse events was comparable
in both the Lexapro and placebo groups. The most common adverse events reported
by Lexapro-treated patients were headache, nausea and insomnia.
Panic disorder is an anxiety disorder characterized by panic attacks, which are
brief episodes of intense fear accompanied by multiple physical symptoms. These
"attacks" happen repeatedly and unexpectedly in the absence of any external
threat or other mental disorder. About 2.4 million American adults between the
ages of 18 and 54 have panic disorder in any given year. Women are also twice as
likely to suffer from panic disorder as men. Panic disorder can occur with other
anxiety disorders, depressive disorders, or substance abuse.
Lexapro and Social Anxiety Disorder
Finally, in another study presented at the ADAA meeting, Austrian researchers
from the University Hospital of Vienna reported that Lexapro demonstrated a
significant improvement relative to placebo in a clinical trial of patients with
social anxiety disorder.
Following a one-week, single-blind placebo lead-in period, 358 patients with
social anxiety disorder were randomized to 12 weeks of double-blind,
flexible-dose treatment with Lexapro or placebo. With flexible dosing, patients
treated with Lexapro could be titrated to an increased dosage, after four, six
or eight weeks of treatment, if needed. Lexapro was well tolerated by patients
in the study. The most common adverse events reported by Lexapro-treated
patients were headache, nausea and insomnia.
Based on the primary measurement tool, the Liebowitz Social Anxiety Scale
(LSAS), which measures a patient's level of fear and avoidance of performance
and/or social situations, Lexapro-treated patients showed a significant
improvement relative to placebo. Secondary assessments, including the Clinical
Global Impressions scale (CGI-S, CGI-I), which indicates a patient's severity
and improvement of symptoms, as well as two of three items on the Sheehan
Disability Scale (SDS), which indicate how the patient handles basic everyday
life activities, such as work and family life, also showed a significantly
better therapeutic effect for Lexapro compared to placebo treatment.
Social phobia is the third most common psychiatric disorder in the United
States, after depression and alcohol dependency. It affects about 5.3 million
Americans, or about 3.7 percent of people ages 18-54.
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 to create a single-enantiomer drug. Celexa is
a racemic mixture with 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.
About Forest Laboratories and Its Products
Forest Laboratories (NYSE: FRX) develops, manufactures, and sells ethical
pharmaceutical products that are used for the treatment of a wide range of
illnesses.
Forest Laboratories' growing line of products includes: Celexa(TM), which has
been prescribed for more than 8 million U.S. patients and is the fastest growing
antidepressant in the U.S.; Tiazac(R) (diltiazem HCL), a once-daily diltiazem,
which is indicated for the treatment of angina and hypertension; and Aerobid(R)
(flunisolide), an inhaled steroid indicated for the treatment of asthma.
Other products in Forest's development pipeline include: memantine for
Alzheimer's disease and neuropathic pain, lercanidipine for hypertension,
acamprosate for alcohol dependence, dexloxiglumide for irritable bowel syndrome,
neramexane for various central nervous system disorders, Aerospan(R) for asthma,
and ALX-0646 for migraine headache.
The Danish pharmaceutical firm H. Lundbeck A/S developed both citalopram and
escitalopram.
Except for the historical information contained herein, this release contains
forward-looking statements that involve a number of risks and uncertainties,
including the difficulty of predicting FDA approvals, acceptance and demand for
new pharmaceutical products, the impact of competitive products and pricing, the
timely development and launch of new products, and the 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, 2001, and the quarterly reports
on Form 10-Q for the periods ended June 30, 2001 and September 30, 2001, and
December 31, 2001.