ARTICLE: FDA Panel Recommends Alzheimer's Drug's OK

[Murray Charters <mcharters@xxxxxxxxxxxxxx>]

FDA Panel Recommends Alzheimer's Drug's OK
Memantine could be 1st drug in U.S. for later stage disease

By Jamie Talan
STAFF WRITER, Staff writer Randi Marshall contributed to this story.

September 25, 2003

A Food and Drug Administration panel yesterday recommended approval of the 
Alzheimer's medicine memantine. The drug
will be the first approved for patients in advanced stages of the mind-robbing 
disease, if the FDA accepts the
recommendation.

The drug has been used in Europe for more than a decade for Parkinson's 
disease. Last year, it was approved in Europe
for Alzheimer's. It works on a different brain system than drugs currently 
available in this country for mild
Alzheimer's. Final approval is expected within the next six weeks.

"There is enough there to make a good case for this drug," said Zaven 
Khachaturian, senior science adviser to the
Alzheimer's Association and former director of Alzheimer's research at the 
National Institutes of Health. "It gives
physicians and family members another option for treatment. What's more, it's 
targeted for moderate to severe cases,
and we haven't had anything to offer these patients."

"This is wonderful news," said Dr. Barry Reisberg, professor of psychiatry at 
New York University School of Medicine
and lead investigator of one of three studies used to make the case before the 
federal advisory panel during a hearing
yesterday. Reisberg and his colleagues studied 252 patients with moderate to 
severe Alzheimer's disease, treating half
with 20 milligrams of memantine for 28 weeks. At the end of the study, patients 
taking the medicine had little evidence
of cognitive decline when compared with those on placebo, who continued to 
worsen.

That study, published earlier this year in the New England Journal of Medicine, 
showed that the medicine slowed the
normal progression of the disease by 50 percent, with fewer side effects, 
compared with those on a placebo.

Many of the patients had progressed to the point where they could no longer 
pick out their clothes or put them on. They
were still living in the community with support, but were in the final stage 
before institutionalization, Reisberg
said. In his study, 80 percent on memantine were helped, with the disease 
process stabilized in many cases.

The other two studies showed similar results, Reisberg said. However, the 
drug's developer, Manhattan-based Forest
Laboratories, issued a news release a few months ago indicating that a study 
conducted to test memantine on milder
symptoms found it did not have much impact at that stage of the disease.

There are roughly 4.5 million Americans with Alzheimer's, a progressive 
dementia that robs people of their memories.

In another study used to support the drug's approval, Dr. Pierre Tariot of the 
University of Rochester and his
colleagues added memantine to the treatment plans of patients taking the 
medicine Aricept for at least six months. They
were compared with patients on Aricept and a placebo. Those who took memantine 
plus Aricept showed less decline and, in
some instances, some improvement compared with when they started. "If you add 
memantine, you get more benefit," said
Dr. Steven Ferris, director of the Alzheimer's disease center at NYU's 
Silberstein Institute.

Even though many had expected the approval, investors rallied on yesterday's 
decision, sending Forest's stock up $2.97,
or just over 6 percent, to close at $51.70 on the New York Stock Exchange.

Forest spokesman Charles Triano said the company expects to be able to market 
the drug within a few months of FDA
approval, which could come around Oct. 19.

Staff writer Randi Marshall contributed to this story.

SOURCE: Newsday


* * *

----------------------------------------------------------------------
To sign-off Parkinsn send a message to: mailto:listserv@xxxxxxxxxxxxxxxxxxxx
In the body of the message put: signoff parkinsn