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Namenda Alzheimer’s Medication Now Available in
Liquid
Only FDA-approved drug for moderate-to-severe
Alzheimer’s Disease
Aug. 19, 2005 – The only drug approved by the Food
and Drug Administration for the treatment of moderate-to-severe
Alzheimer’s disease – Namenda (memantine HCl) - is now available in an
oral solution formulation.
Oral solution offers an alternative that may make
administration of Namenda easier for those patients who have trouble
swallowing tablets, and for those who prefer taking medication in liquid
form, said the announcement from Forest Laboratories, Inc.
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About Alzheimer's Drugs |
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“Alzheimer’s: Searching
for a Cure” in FDA Consumer Magazine, 06-29-2004 Update
Treating the Symptoms
There is no cure for AD, but there are drugs
to treat some of the symptoms. The Food and Drug Administration
has approved four prescription drugs for people with
mild-to-moderate AD: Cognex (tacrine), Aricept (donepezil),
Exelon (rivastigmine), and Reminyl (galantamine). "All of them
work by the same mechanism," says Russell Katz, M.D., director
of the FDA's Division of Neuropharmacological Drug Products. The
drugs increase the level in the brain of acetylcholine--a
chemical that nerves use to communicate with each other. "People
with AD are deficient in this neurotransmitter, and the drugs
work by inhibiting an enzyme called cholinesterase that breaks
down the acetylcholine," says Katz. "These cholinesterase
inhibitors have an effect on the symptoms, but we have no
evidence that they have any effect on the underlying progression
of the disease. During treatment, as far as we know, the nerve
cells are still dying and the various plaques and tangles are
still forming."
"There's healthy debate about whether these
drugs actually affect the course of the illness," says Trey
Sunderland, M.D., chief of the Geriatric Psychiatry Branch of
the National Institute of Mental Health (NIMH). According to the
data, says Sunderland, "If people are on the cholinesterase
inhibitors, they tend to go to nursing homes later than people
who are not on the inhibitors." Some researchers have reported a
delay of up to 22 months in going to nursing homes, he adds.
Another drug, Namenda (memantine), is
approved to treat people with moderate-to-severe Alzheimer's
disease. This drug is thought to work by blocking the action of
glutamate, a brain chemical that may be overactive in people
with AD.
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The oral solution of Namenda is equivalent on a
milligram per milligram basis to the Namenda tablets and is administered
in the same manner. Namenda oral solution is available for prescription
in a 2 mg/ml concentration, 360 ml (12 oz) bottle.
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 (October 17, 2003) based on three studies of Namenda used alone
or in combination with another Alzheimer’s disease drug.
“Although memantine helps treat the symptoms of
Alzheimer’s Disease in some patients, there is no evidence that it
modifies the underlying pathology of the disease,” said the FDA approval
announcement.
FDA Commissioner at the time, Mark McClellan, M.D.,
Ph.D. said, "The approval of memantine is good news for Alzheimers’
Disease patients. This is the first drug shown to have an effect on the
symptoms of moderate to severe Alzheimer’s Disease, and shows a low
incidence of minor side effects."
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 (≥5% and higher than placebo) were dizziness, confusion,
headache, and constipation. In patients with severe renal impairment,
the dosage should be reduced, the company says.
About Alzheimer’s
Alzheimer’s Disease, which affects about 4.5 million Americans,
primarily senior citizens, is a degenerative condition affecting memory,
judgment and the ability to reason.
About Forest Laboratories and Its Products
Forest Laboratories markets Namenda (memantine HCl) in the United States
under license from Merz Pharma GmbH & Co. of Germany. Lundbeck, under
license from Merz, markets memantine as Ebixa®, and Merz markets
memantine as Axura® and as Akatinol®, each in a number of markets
worldwide. Ebixa, Axura, and Akatinol are registered trademarks Merz
Pharma GmbH & Co.
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