BALTIMORE, Feb. 23 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced that data from the first U.S. clinical trial evaluating
Namenda(TM) (memantine HCl) as monotherapy for the treatment of mild to
moderate Alzheimer's disease were presented for the first time today at the
American Association for Geriatric Psychiatry (AAGP) Annual Meeting in
Baltimore, Maryland. In this study, patients treated with Namenda performed
significantly better than patients who received placebo on both primary
outcome measures of cognition and global functions. Namenda was very well
tolerated in the study, confirming results of previous studies in patients
with moderate to severe Alzheimer's disease in which adverse effects with
Namenda were comparable to placebo.
"These results are good news for the Alzheimer's community because they
suggest that using Namenda in the early stages of Alzheimer's disease may
translate into a patient's ability to perform tasks such as communicating with
caregivers or remembering names and phone numbers for longer periods of time
compared to their ability if they did not receive treatment," said Elaine
Peskind, M.D., an investigator on the study and Professor, Department of
Psychiatry and Behavioral Sciences, University of Washington School of
Medicine. "As Namenda has a mechanism of action distinct from the currently
approved treatments for mild to moderate Alzheimer's disease and a favorable
safety and tolerability profile, it promises to give physicians, caregivers,
and patients a new and different treatment option for mild to moderate
Alzheimer's disease based upon FDA approval in the future."
Study Results
Patients who received Namenda performed significantly better on both
primary outcome measures of cognition and global function than those patients
given placebo. The two primary outcome measures were the Alzheimer's Disease
Assessment Scale -- cognitive subscale (ADAS-cog) and the Clinician's
Interview-Based Impression of Change -- Plus version (CIBIC-Plus). The
ADAS-cog is a commonly used measure of cognitive function frequently used to
evaluate mild to moderate Alzheimer's disease. It includes items which
evaluate different types of cognitive functions like memory and language. As
assessed by the ADAS-cog, patients receiving Namenda maintained cognitive
abilities above baseline for the entire 24-week study. Patients receiving
placebo exhibited a progressive decline during the study with the difference
between the two treatment groups being statistically significant (p=0.003).
The CIBIC-Plus is a global measure of a patient's overall status evaluating
their cognition, behavior, and activities of daily living. The results of the
study reveal that patients receiving Namenda had significantly better global
status compared to those taking placebo as assessed by the CIBIC-Plus
(p=0.004). Namenda was safe and well tolerated, with patients on Namenda
experiencing adverse events at overall rates that were comparable to patients
on placebo.
Based on the positive results of this study, Forest Laboratories plans to
submit to the U.S. Food and Drug Administration (FDA) a supplemental New Drug
Application for a mild to moderate Alzheimer's disease indication for Namenda
in mid-2004.
Study Design
The six-month, randomized, double-blind, parallel group,
placebo-controlled Phase III study involved 403 patients with mild to moderate
Alzheimer's disease at 42 U.S. sites. The study was designed to evaluate the
safety and efficacy of Namenda given as monotherapy to patients with mild to
moderate Alzheimer's disease at a daily dosage of 10 mg twice a day.
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.
In all clinical trials, Namenda has been safe and well tolerated. Namenda
is contraindicated in patients with known hypersensitivity to memantine HCl or
to any excipients used in the formulation. The most common adverse events
reported with Namenda vs placebo (> or = 5% and higher than placebo) were
dizziness, confusion, headache, and constipation. In patients with severe
renal impairment the use of Namenda has not been systematically evaluated and
is not recommended.
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.