Drug for Late Alzheimer’s Moves Closer to Approval

September 25, 2003

September 25, 2003

The first drug shown to be effective against the more severe stages of Alzheimer’s disease moved a step closer to approval this week when an advisory panel to the Food and Drug Administration (FDA) recommended that it be approved for sale in the United States.

The drug, called memantine, has been shown to produce modest benefits in some patients with moderate to severe Alzheimer’s. It works differently than the currently approved Alzheimer’s drugs– Aricept, Exelon, Reminyl and Cognex — which are prescribed only for the early stages of the disease.

“If approved, memantine could offer a new option for patients suffering from the more advanced stages of Alzheimer’s disease,” says Samuel E. Gandy, M.D., Ph.D., Chairman of the Scientific Advisory Board at the Fisher Center for Alzheimer’s Research Foundation. “It is important for patients and families to realize that memantine, like the currently available Alzheimer’s drugs, may provide only limited benefits at best. Still, this is an important demonstration that it is possible to show a treatment response even in moderate to late stages of disease.”

Memantine gained widespread attention in April when a study revealed it to be the first effective drug for the later stages of Alzheimer’s. The study, led by Barry Reisberg, M.D. of the Zachary and Elizabeth M. Fisher Alzheimer’s Disease Education and Resources Program at New York University Medical Center, found it both safe and effective for moderate to severe disease.

Namenda: New Drug Option?

Drug treatment of Alzheimer’s remains difficult because cognitive improvements are often small and hard to detect. Researchers may detect small but statistically significant improvements on memory test while the family notices little or no improvement in day-to-day functioning of patients. On the other hand, until more effective drugs and a cure for the disease are found, any improvements are welcome, and existing drugs have provided modest benefits for some, at least for a while.

A recommendation for approval by the FDA advisory does not guarantee that it will be granted full approval, though the agency usually follows the panel’s recommendation. Forest Laboratories, the maker of the drug, said they expected an agency decision within a month. If memantine is approved, doctors will be able to prescribe the drug, which will be sold under the brand name Namenda. It would likely take several months after approval before it was widely stocked in drugstores.

Currently, memantine has been approved in Germany and other European countries. Some Americans, desperate for any measure that will help, have been importing the drug by mail or ordering it over the Internet.

By Toby Bilanow, Medical Writer for www.ALZinfo.org. The Alzheimer’s Information Site. Reviewed by Samuel E. Gandy, M.D., Ph.D., Chairman of the Scientific Advisory Board, Fisher Center for Alzheimer’s Research Foundation.


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