Forest Laboratories, Inc. Announces Positive Results of Memantine Study of Once-Daily Formulation
February 05 2008 - 8:02AM
PR Newswire (US)
NEW YORK, Feb. 5 /PRNewswire-FirstCall/ -- Forest Laboratories,
Inc. (NYSE:FRX) today announced preliminary results of a Phase III
study of memantine HCl (currently marketed as Namenda(R), a
twice-daily immediate- release formulation) in a novel once-daily
formulation. The study evaluated the efficacy, safety, and
tolerability of an innovative, proprietary, 28 mg memantine
extended-release, once-daily formulation compared to placebo in
outpatients with moderate to severe Alzheimer's disease currently
treated with a cholinesterase inhibitor. The results indicate that
patients treated with memantine 28 mg extended-release formulation
experienced statistically significant benefits in cognition and
clinical global status compared to placebo. Additional data from
the study are expected to be presented later in the year. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) The
recommended dose for Namenda is currently 10 mg two times a day (20
mg/day), or for patients with severe renal impairment 5 mg twice a
day (10 mg/day). Patients in this study were titrated to 28 mg/day
in a once-daily modified release formulation. Namenda is currently
available in tablets or liquid form. "The higher dosage and
once-daily formulation will provide patients with the efficacy and
tolerability expected from Namenda, in a more convenient once-daily
form," said Ivan Gergel, M.D., Senior Vice President of Scientific
Affairs at Forest Laboratories and President of the Forest Research
Institute. "Based on the results of this study, Forest plans to
pursue a new drug application for the memantine extended-release
once-daily formulation." About the Study A randomized,
double-blind, placebo-controlled trial of 677 outpatients taking a
cholinesterase inhibitor was conducted in multiple centers in
Argentina, Chile, Mexico, and the U.S. Patients in the 24-week
study were randomly assigned to receive either 28 mg/day of
memantine 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 significant 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 extended
release compared to those treated with placebo (p=0.001 for SIB and
p=0.008 for CIBIC-Plus, both using the pre-defined last observation
carried forward analyses). The study also showed that the
once-daily memantine extended-release formulation was well
tolerated. The most common adverse events occurring at a higher
rate than placebo were dizziness, diarrhea and headache. About
Alzheimer's Disease Alzheimer's disease is a progressive 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. Published reports project that by 2050 more
than 16 million people in the U.S. will have Alzheimer's disease.
Currently, all Alzheimer's disease medications approved in the U.S.
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 as
monotherapy or in patients on a stable dose of donepezil. 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 (greater than or equal
to 5% and higher than placebo) in placebo-controlled trials in
patients with Alzheimer's disease were dizziness, confusion,
headache, and constipation. In patients with severe renal
impairment, dosage should be reduced. About Forest Laboratories and
Its Products Forest Laboratories (http://www.frx.com/) is a
U.S.-based pharmaceutical company dedicated to identifying,
developing, and delivering products that make a positive difference
in peoples' lives. Forest Laboratories' growing product line
includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major
depressive disorder and generalized anxiety disorder; Namenda(R)
(memantine HCl), an N-methyl D-aspartate (NMDA)-receptor antagonist
indicated for the treatment of moderate to severe Alzheimer's
disease; Campral(R)* (acamprosate calcium), indicated in
combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are
abstinent at treatment initiation; and Bystolic(TM) (nebivolol), a
beta-adrenergic receptor blocking agent indicated for the treatment
of hypertension. In addition to our growing product line, Forest
also co-promotes the Daiichi Sankyo, Inc. products Benicar(R)*
(olmesartan medoxomil), an angiotensin receptor blocker; Benicar
HCT(R)* (olmesartan medoxomil-hydrochlorothiazide), an angiotensin
receptor blocker and diuretic combination product; and AZOR(TM)*
(amlodipine and olmesartan medoxomil), a calcium channel blocker
and angiotensin receptor blocker combination product, all indicated
for the treatment of hypertension. Forest Laboratories markets
Namenda(R) (memantine HCl) in the United States under license from
Merz Pharma GmbH & Co. KGaA of Germany. *Azor is a trademark of
Daiichi Sankyo, Inc.; Benicar and Benicar HCT are registered
trademarks of Daiichi Sankyo, Inc.; and Campral is a registered
trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany. 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 each of Forest Laboratories' and Mylan's Annual Reports on
Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC
filings. http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, , or Pamela Chait of
Fleishman-Hillard for Forest Laboratories, Inc., +1-212-453-2482,
Web site: http://www.frx.com/
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