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Forest Laboratories
Inc. has resubmitted its application to the U.S. Food and Drug
Administration for approval of memantine, a proposed treatment
for Alzheimers disease.
The company
withdrew the application in September after the FDA requested
that deficiencies be remedied (see earlier Alzheimer
Week story).
A spokesperson
for Forest said the company planned to add final data by the end
of January from a Phase III trial, which has produced positive
preliminary results in treating moderate to severe Alzheimer's.
Dr. Pierre
Tariot, a University of Rochester professor who oversaw the trial,
said Alzheimers patients who received a combination of memantine
and donepezil performed significantly better than those who got
donepezil and a placebo.
Those getting
the memantine combination also showed less decline in activities
associated with daily living.
Donepezil,
sold under the name Aricept, currently is given alone to many
patients with mild to moderate forms of Alzheimers.
At the
end of the six months, those who took the combination were performing
better than when they started the drugs, said Tariot. "The
combination of drugs is clearly superior."
Other
sources: Forest, Rochester Democrat and Chronicle
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