October 17, 2003
The Food and Drug Administration (FDA) today approved Namenda (brand name memantine), the first drug shown to be effective against the more severe stages of Alzheimer's disease, for sale in the United States. The move means that doctors will now be able to prescribe the drug for persons suffering from the later stages of the mind-robbing ailment. Forest Labs, the company that distributes the drug in the United States, said that they expect pharmacies and drugstores should be stocked with the medication within several months, by January 2004.
Studies have demonstrated that Namenda can 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.
"Memantine (Namenda) offers 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."
Forest Labs also announced that interested persons can get more information on Namenda by calling 1-877-2-NAMENDA (1-877-262-6363).
Namenda (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.
Drug treatment of Alzheimer's remains difficult because cognitive improvement 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.
Currently, Namenda (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. Now they will be able to get the drug through their doctor's prescription. If you are interested in obtaining the drug, consult with your doctor whether it is right for you or your loved one.
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.