- Results Presented at ICAD 2008 Highlight Significant Improvement in
Cognitive Performance and Global Clinical Status in Patients with
Alzheimer's Disease -
CHICAGO, July 30 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) presented today positive Phase III data of a once-daily
extended-release formulation of Namenda(R) (memantine HCl) at the 2008
Alzheimer's Association International Conference on Alzheimer's Disease
(ICAD). The study evaluated the efficacy, safety and tolerability of an
innovative, proprietary, 28 mg once-daily extended-release formulation of
Namenda compared to placebo in outpatients with moderate to severe
Alzheimer's disease already being treated with a cholinesterase inhibitor
(donepezil, galantamine or rivastigmine).
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
In the study, patients treated with once-daily extended-release Namenda
experienced significant improvements in cognitive performance and global
clinical status compared to those receiving placebo. Patients treated with
once-daily extended-release Namenda also experienced significant
improvements in verbal fluency and behavioral symptoms as compared to
placebo. The results build on preliminary findings announced by Forest in
February.
"While there is no cure or existing treatment to prevent Alzheimer's
disease, there are currently-available FDA-approved treatments, such as
combination therapy with memantine and a cholinesterase inhibitor, which
can alleviate symptoms by providing cognitive, functional, and behavioral
benefits," said George Grossberg, MD, Director of Geriatric Psychiatry at
Saint Louis University School of Medicine, and the lead investigator who
presented the data. "These findings reinforce the safety, tolerability and
efficacy of memantine in a newly-developed once-a-day formulation."
Marco Taglietti, MD, Executive Vice President and Chief Medical Officer
at Forest added, "With this novel formulation, the efficacy and
tolerability of Namenda is delivered in a more convenient, once-daily
dose."
About the Study
A randomized, double-blind, placebo-controlled trial of 677 outpatients
already taking a cholinesterase inhibitor was conducted in multiple centers
in the United States, Argentina, Chile, and Mexico. Patients in the 24-week
study were randomly assigned to receive either 28 mg/day of memantine
once-daily extended-release or placebo. The primary endpoints evaluated
were change from baseline on the Severe Impairment Battery (SIB) and the
Clinician's Interview-Based Impression of Change Plus Caregiver Input
(CIBIC-Plus) rating at week 24. The study showed statistically
significantly higher cognitive abilities, as measured by the SIB, and
clinical global status, as measured by the CIBIC-Plus, in patients treated
with memantine 28 mg once-daily extended-release compared to placebo
(p=0.001 for SIB and p=0.008 for CIBIC-Plus, both using pre-defined last
observation carried forward analyses). The CIBIC-Plus is a global measure
of a patient's overall status evaluating cognition, behavior, and
activities of daily living.
Results for a secondary endpoint and additional assessment variables
reinforced the positive findings seen with the primary endpoints.
Assessments were conducted to evaluate change in behavior from baseline
using the Neuropsychiatric Inventory (NPI) at 24 weeks and change in verbal
fluency from baseline using the Verbal (Semantic) Fluency Test at 24 weeks.
Memantine provided significant benefits over placebo (p=0.005 for NPI and
p=0.004 for verbal fluency). Measurement of daily living activities using
the 19-item AD Cooperative Study-Activities of Daily Living scale
(ADCS-ADL) demonstrated maintenance of function during the study period,
but this was not significantly different from placebo (p=0.18).
The study also demonstrated that once-daily extended-release memantine
was well tolerated. The treatment-emergent AEs (TEAEs) profile was similar
between the groups; no TEAEs were experienced by greater than or equal to
5% of memantine patients, and at an incidence at least twice that of the
placebo group. The most common adverse events occurring at a higher rate
than placebo were dizziness (4.7% vs 1.5%), diarrhea (5.0% vs 3.9%), and
headache (5.6% vs 5.1%).
About Alzheimer's Disease
Alzheimer's disease is a progressive, degenerative disease of the brain
and the most common type of dementia. Dementia is used to describe the
progressive loss of cognitive, intellectual, or functional abilities. By
2050, the number of individuals age 65 and over with Alzheimer's disease
could range from 11 million to 16 million. Currently, all Alzheimer's
disease medications approved in the US other than Namenda belong to a class
of agents called cholinesterase inhibitors.
About Namenda
Namenda (memantine HCl) is the first in a class of medications with a
unique mechanism of action that focuses on the glutamate pathway, a target
for the treatment of Alzheimer's disease. Indicated for the treatment of
moderate to severe Alzheimer's disease, the FDA approved Namenda in October
2003 based on three studies of Namenda used alone or in combination with
another Alzheimer's disease drug. At present, the recommended dose of
Namenda is 10 mg two times a day (20 mg/day).
Namenda is contraindicated in patients with known hypersensitivity to
memantine HCl or any excipients used in the formulation. The most common
adverse events reported with Namenda vs placebo (greater than or equal to
5% and higher than placebo) were dizziness, confusion, headache, and
constipation. In patients with severe renal impairment, dosage should be
reduced.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a US-based pharmaceutical company
with a long track record of building partnerships and developing and
delivering products that make a positive difference in people's lives. In
addition to its well-established franchises in therapeutic areas of the
central nervous and cardiovascular systems, Forest's current pipeline
includes product candidates in all stages of development and across a wide
range of therapeutic areas. The company is headquartered in New York, NY.
To learn more about Forest Laboratories, visit http://www.FRX.com.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the 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
Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings.
SOURCE Forest Laboratories, Inc.
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Related links:
http://www.frx.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Frank Perier, Jr., Senior Vice President -
Finance and Chief Financial Officer, Forest Laboratories, Inc.,
+1-212-224-6611, Frank.Perier@frx.com; or Cassie Ercanbrack,
Fleishman-Hillard, +1-212-453-2391,
Cassie.Ercanbrack@fleishman.com
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