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WASHINGTON (AP) -- Americans with advanced
Alzheimer's disease soon can try the first treatment proved
effective for late stages of the mind-robbing illness.
Memantine
should be on pharmacy shelves by January under the brand
name Namenda, its marketer says. The drug has been sold
for two decades in Germany, desperately sought by many U.S.
families since word of its promise began spreading last
year.
It was
approved Friday by the Food and Drug Administration.
The
marketer, Forest Laboratories Inc., says it has been getting
over 1,000 calls a month from people waiting to buy it.
Others have been buying supplies overseas via the Internet.
Memantine
does not offer miraculous benefits, said the FDA, worried
about giving families false hope.
The
drug can delay worsening from Alzheimer's, however, allowing
people to maintain functions such as going to the bathroom
independently for a few months longer.
It's
the first option specifically for people with moderate to
severe Alzheimer's symptoms. Today's other four Alzheimer's
medications are proved to work only in early stages of the
disease.
Perhaps
more importantly, memantine works on a different brain chemical
than the other four drugs. That means for the first time,
doctors can combine different Alzheimer's therapies in hopes
of better results.
Today,
some families import memantine from Europe for prices ranging
from $147 to $240 for a month's supply. Forest Laboratories,
which licensed the drug from German maker Merz Pharmaceuticals,
refused to say whether U.S. prices would fall within that
range, saying it had not yet decided.
Ruth
Hobbs, 74, of Winchester, Ky., has been taking a combination
of memantine and the older Alzheimer's drug, Aricept, for
about a year in a research project.
A year
ago, Hobbs couldn't remember Thanksgiving had even occurred.
This year, she's planning to help cook, and her family credits
the combination with allowing her to continue living alone.
"We
had reached a point where we were saying, `What are we going
to do about Mama?'" recalled DeEtta Blackwell, Hobbs'
daughter. Now, "we're not waiting for the other shoe
to drop."
About
4.5 million Americans have Alzheimer's, and a million of
them are believed to suffer severe symptoms. It afflicts
mainly the elderly, robbing them of memory and the ability
to care for themselves. There is no known cure or prevention;
medications only temporarily slow the inevitable worsening.
Memantine
has been used in Germany for two decades to treat different
brain disorders. In 1999, the first solid research was published
that suggested memantine could help moderate to severe Alzheimer's;
the drug won Europewide approval for that use last year.
In U.S.
studies, some patients experienced improvements in memory
and other skills, like Hobbs.
But
for most, the drug instead slowed the pace of deterioration,
by some measures at half the pace of those given a dummy
drug. Performance was measured on cognitive tests and by
tracking how well patients performed certain functions such
as getting dressed or bathing themselves.
"The
effect wasn't overwhelming," cautioned FDA neurologic
drugs chief Dr. Russell Katz. "But they did better
than they would have done if they hadn't gotten anything."
And
for families facing the prospect of round-the-clock care,
maintaining even some simple activities for an extra six
months is very important, said Zaven Khachaturian, senior
science adviser of the Alzheimer's Association.
"Having
another one, that operates on a different principle, is
welcome news," he said.
The
four other Alzheimer's medications -- Aricept, Exelon, Reminyl
and Cognex -- work by delaying the breakdown of a brain
chemical called acetylcholine, which is vital for nerve
cells to communicate. In contrast, memantine blocks excess
amounts of another brain chemical, called glutamate, that
can damage or kill nerve cells.
Doctors
don't yet know whether memantine works better when given
in early stages of Alzheimer's; those studies are under
way.
Copyright
2003 The Associated Press. All rights reserved. This material
may not be published, broadcast, rewritten, or redistributed.
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