BALTIMORE, Feb. 23 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today the presentation of new data on behavioral
outcomes from the first clinical trial evaluating the treatment of patients
with moderate to severe Alzheimer's disease with a combination of two
available Alzheimer's drugs: Namenda(TM) (memantine HCl) and donepezil. The
results from the behavioral analysis demonstrate that treatment with Namenda
and donepezil is associated with improvement in behaviors such as agitation,
irritability and appetite changes in patients with moderate to severe
Alzheimer's disease compared to baseline, while patients treated with
donepezil and placebo declined relative to their baseline status. The study's
new in-depth behavioral analysis was presented today at the American
Association for Geriatric Psychiatry (AAGP) Annual Meeting in Baltimore,
Maryland. Preliminary results of the study findings were recently reported in
the Journal of the American Medical Association.
"The behavioral problems that are generally seen in the later stages of
Alzheimer's disease ranging from aggression to sleep disturbances can
dramatically increase caregiver burden and often lead to placing patients in
nursing homes," said Jeffrey L. Cummings, M.D., August Rose Professor of
Neurology and Professor of Psychiatry and Biobehavioral Sciences at the David
Geffen School of Medicine, University of California, Los Angeles. "Namenda
diminished behavioral symptoms of Alzheimer's disease in this study, and this
may ease caregiver burden and potentially keep a patient at home with his or
her family longer."
Namenda, now available in the United States, is the first and only therapy
approved to treat the moderate to severe stages of Alzheimer's disease.
Namenda has a unique mechanism of action and it has been demonstrated to be
safe and effective when administered as monotherapy or in combination with
donepezil. All other approved treatments, including donepezil, belong to a
class of drugs called acetylcholinesterase inhibitors (AChEI) and are
indicated only for patients in the mild to moderate stages of Alzheimer's.
Namenda Shown to Help Reduce Behavioral Disturbances in Alzheimer's
Patients
Data demonstrate that patients receiving the combination of Namenda and
donepezil experienced an overall reduction in behavioral disturbances and
psychiatric symptoms relative to baseline, while patients treated with
donepezil alone experienced an increase or worsening of these symptoms. The
frequency and severity of behavioral disturbances were evaluated in aggregate
with the Neuropsychiatric Inventory (NPI), a standard assessment scale that
measures a range of common behavioral symptoms often associated with
Alzheimer's patients. The difference between the two groups in the change
from baseline at the six-month endpoint on the NPI in this trial was
statistically significant (p=0.002). Several individual behaviors that
showed statistically significant improvement compared to baseline in patients
treated with Namenda compared to placebo treatment included:
agitation/aggression (p=0.001), irritability/lability (p=0.005) and
appetite/eating change (p=0.045).
In general, the incidence of treatment-emergent adverse events was similar
in patients treated with Namenda/donepezil and the placebo/donepezil
combination. A significantly greater percentage of patients in the
Namenda/donepezil group (85 percent vs. 75 percent) completed the study
compared to the placebo/donepezil group (p=0.011).
The results of this analysis expand upon the data from this landmark study
published earlier this year in The Journal of the American Medical Association
(Vol 291, No. 3) that demonstrated that patients with moderate to severe
Alzheimer's disease taking a combination of Namenda and donepezil experienced
significant positive cognitive, functional, and global benefits compared to
patients treated with donepezil alone.
Study Design
The in-depth behavioral data presented today were derived from the first
study designed to evaluate the safety and efficacy of treating moderate to
severe Alzheimer's disease patients with a combination of Namenda and
donepezil. The six-month study included 404 patients at 37 sites and was a
prospectively designed, double-blind, placebo-controlled, Phase III trial.
Study patients were required to receive a stable dose of donepezil for at
least three months; all patients were treated with donepezil for a minimum of
six months. Patients were then randomized to receive donepezil plus 10 mg of
Namenda twice a day, or donepezil and placebo.
Behavioral Problems and Alzheimer's Disease
Alzheimer's disease can cause a person to exhibit marked behavioral
changes that are difficult for caregivers to manage. These symptoms can
include withdrawal, apathy, depression, hostility, anger, and aggression, with
most patients exhibiting some or all of these symptoms during the course of
the disease. As the disease progresses, behavioral symptoms often increase in
frequency and severity. Managing a patient's behavioral symptoms is an
important component of treatment regimens for Alzheimer's disease.
About Namenda
Namenda (memantine HCl) is the first in a new class of medications with a
unique mechanism of action that focuses on the glutamate pathway, a new target
for the treatment of Alzheimer's disease. Indicated for the treatment of
moderate to severe Alzheimer's disease, Namenda was recently approved by the
FDA based on the results of three placebo-controlled studies which
demonstrated Namenda's efficacy as monotherapy, or when used in combination
with the commonly prescribed drug, donepezil. Results from the two U.S.
studies in moderate to severe Alzheimer's disease have been published in The
New England Journal of Medicine and The Journal of the American Medical
Association.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro(TM), an
SSRI antidepressant indicated for the initial and maintenance treatment of
major depressive disorder and Generalized Anxiety 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, 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.
* Benicar(R) is a registered trademark of Sankyo Pharma, Inc.
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.