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Memantine (Namenda) Found Effective for Advanced
Alzheimer's Disease
Clinicians, caregivers and scientific tests support
earlier FDA approval
Jan. 10, 2006 - Memantine, marketed as Namenda, was
approved in 2003 as the first drug okayed by the FDA for the treatment
of moderate to severe Alzheimer's disease. A new study reported today
confirms that it appears safe and effective for this use.
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FDA Advisory Committee Recommends Approval for Namenda (Memantine HCl) For Moderate to Severe Alzheimer's Disease
September 25, 2003 -- Forest Laboratories announced that an advisory committee to the U.S. Food and Drug Administration (FDA) unanimously recommended the approval of Namenda(TM), previously known by its generic name memantine HCl, for the treatment of moderate to severe Alzheimer's disease.
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According to the FDA, the drug is an N-methyl-D-asparate
(NMDA) antagonist and is thought to work by blocking the action of the
chemical glutamate. "Although memantine hydrochloride helps treat the
symptoms of Alzheimer’s disease, there is no evidence that it modifies
the underlying pathology of the disease," reports the FDA.
The drug also is available in the European Union
and Australia.
The study supporting the FDA decision is reported
in the January issue of Archives of Neurology, one of the JAMA/Archives
journals.
Millions of people worldwide have Alzheimer disease
(AD), a progressive neurodegenerative disorder, according to background
information in the article. Various chemical and other processes in the
brain may contribute to the development of the condition.
Memantine appears to act on one of those pathways,
which involves the neurotransmitter glutamate, the authors report.
Barry Reisberg, M.D., from the New York University
School of Medicine, and colleagues conducted a 24-week open-label
extension trial. In this type of trial, participants who had previously
been part of a double-blind study—where some were taking an active drug
and some were taking a placebo—were all given the same amount of the
active drug.
For this study, 175 patients with moderate to
severe AD who completed the previous 28-week study received 20 mg of
memantine daily for an additional 24 weeks.
The authors report that during the study, cognitive
tests, reports from caregivers and observations by clinicians all
indicated that memantine was beneficial to AD patients.
“The benefits of memantine seen in the double-blind
phase were again observed when patients treated with placebo were
switched to memantine treatment in the open extension,” they write.
“For the patients who were randomized to memantine
treatment during the double-blind phase, these clinically relevant
benefits also appeared to be maintained in sum.” The completion rate
for the extension phase was high (78 percent) and the adverse event
profile for memantine was similar to that observed in the double-blind
study.
“Previous studies support the use of memantine to
improve cognitive function or delay its decline, reduce the rate of loss
of activities of daily living and reduce or decrease the emergence of
new behavioral symptoms in patients with AD,” writes Jeffrey L.
Cummings, M.D., of the David Geffen School of Medicine at the University
of California, Los Angeles, in an editorial in the magazine.
“These new data from Reisberg and coworkers provide
additional reassurance to prescribing physicians that long-term use of
memantine is safe, continues to have a low rate of adverse effects and
may have continuing beneficial clinical effects.”
Editor’s Note: This study was funded by Merz
Pharmaceuticals GmbH, Frankfurt, Germany. Development of measurements
used in this study was supported by grants from the National Institute
of Aging and the U.S. National Institutes of Health.
Note:Memantine is marketed under the trade name
Namenda by Forest Labs of Jersey City, N.J.
Editor’s Note: Dr. Cummings has served as a
consultant or performed research for AstraZeneca, Avanir, Bristol
Myers-Squibb, Eisai Forest, Janssen, Lilly, Lundbeck, Memory, Merz,
Neurochem, Novartis, Ono, Pfizer, Praecis, Takeda, Sanofi-Aventis,
Sepracor and Wyeth.
More information - Arch Neurol. 2006;63:49-54
www.jamamedia.org.
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