FDA Panel Urges Approval of Alzheimer’s Medication

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

At the meeting in Bethesda, Md., the committee of eight experts agreed that 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 marketer of the drug in the U.S.

It can either approve or not approve the drug; or it can 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 did 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.

Family and friends who care for the 4 million Americans with Alzheimer’s often experience exhaustion and other problems as the disease robs its sufferers of their memories and their ability to care for themselves.

A patient taking Memantine would “stabilize in aspects of thinking, of attention, of participating in daily activities,” said Dr. Lon S. Schneider, an advisor to Forest Laboratories and a USC 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 Dr. Jeffrey L. Cummings, a neurologist and director of the UCLA Alzheimer’s Disease Research Center.

“These are very important goals for patients and families,” Cummings said in an interview. “Of course, what we are still looking for are those drugs that will prevent the onset or reverse the symptoms of Alzheimer’s disease.”

The study of Memantine, led by Dr. Barry Reisberg, a psychiatrist at New York University School of Medicine, involved 252 patients at 32 medical centers. The patients, all with moderate to severe Alzheimer’s and all still living at home, received either 20 milligrams of Memantine daily or the placebo.

Despite the promising findings, researchers still don’t know whether the drug’s benefits last longer than six months.

If approved by the FDA, Memantine would be the first in a new class of drugs prescribed for Alzheimer’s.

There is no known cure for the disease.

The existing medications -- Aricept, Exelon and Reminyl, useful in mild to moderate stages of the disease -- boost levels of a brain-signaling chemical called acetylcholine.

Memantine works by blocking glutamate, which stimulates nerve cells associated with memory and learning.

In excessive amounts, glutamate can be toxic to these nerve cells and is associated with several other neurodegenerative illnesses, such as Huntington’s disease and Parkinson’s disease.

Because Memantine works in a different way, the current treatments could be used along with it, Cummings said.

Reisberg’s study was sponsored by the National Institute on Aging and Merz Pharmaceuticals, the drug’s German manufacturer.

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Times staff writer Jane Allen contributed to this report.