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Archive for Thursday, September 25, 2003

FDA advisers back drug to treat Alzheimer’s

September 25, 2003

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An advisory panel of the federal Food and Drug Administration on Wednesday unanimously recommended approval of a drug that research shows can slow the progression in the later stages of Alzheimer's disease.

At the meeting in Bethesda, Md., the committee of eight experts agreed the drug Memantine is safe and effective for patients with moderate to severe Alzheimer's; the drug already has been approved in Europe.

The FDA has until Oct. 19 to respond to Forest Laboratories Inc., the New York-based U.S. marketer of the drug. It could either approve or not approve the drug; or it could request more information from the company.

The drug showed few, if any, side effects in its first major U.S. clinical trial. Patients experienced about half as much decline in their physical and mental conditions as those who received a placebo, scientists reported in April.

The study also found that patients taking Memantine needed nearly 46 fewer hours of monthly assistance from caregivers.

A patient taking Memantine would "stabilize in aspects of thinking, of attention, of participating in daily activities," said Dr. Lon Schneider, an adviser to Forest and a University of Southern California professor of psychiatry, neurology and gerontology.

"Slowing the progress means that patients' functional abilities can be maintained and their dependency and requirements" for nursing home care can be delayed, said Jeffrey Cummings, a neurologist and director of the Alzheimer's Disease Research Center at the University of California, Los Angeles.

"These are very important goals for patients and families," Cummings said.

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