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FDA approves first drug for moderate to severe Alzheimer's BY NANCY MCVICAR South Florida Sun-Sentinel Posted on Fri, Oct. 17, 2003 FORT LAUDERDALE, Fla. - (KRT) - Alzheimer's patients with more advanced disease soon will have a drug that may prolong their ability to perform simple tasks such as buttoning a shirt, setting the table, or going to the bathroom by themselves. The U.S. Food and Drug Administration on Friday approved the drug memantine, trade name Nemanda, as the first treatment for moderate to severe Alzheimer's, the brain disease that affects an estimated 4.5 million people in this country, slowly robbing them of memory and the ability to care for themselves. About 500 patients in South Florida have participated in clinical trials of the drug. Memantine was developed by Merz, a German company, and has been approved in Europe for several years to treat Parkinson's disease, dementia in the elderly, and to help the recovery of patients in coma. Forest Laboratories, based in New York, licensed the drug from Merz, sponsored the necessary clinical trials, and expects to have it available in pharmacies by sometime in January. Price of the drug has not yet been established. Some desperate families have been importing memantine for their loved ones, while waiting for the FDA to act. "We are very happy that the drug will be available in the United States now," said Scott Fuhr, a spokesman for the Alzheimer's Association of Southeast Florida. "It's a very, very positive thing. It's unfortunate that there's not a cure yet, but it's a step." Dr. Barry Baumel, of Baumel-Eisner Neuromedical Institute, which conducted memantine trials through its offices in Broward, Palm Beach and Miami-Dade counties in Florida, said the drug's effects are not dramatic, but that caregivers may notice subtle improvements in the patient. The drug works on a different set of chemicals in the brain than the other Alzheimer's treatments already in use - Aricept, Exelon, Reminyl and Cognex - which are classified as cholinesterase inhibitors. Memantine is classified as an NMDA receptor antagonist and works to control abnormal levels of the chemical glutamate, thought to be responsible for dysfunction of neurons in the brain and the eventual brain cell death observed in Alzheimer's disease. The drug is in pill form, taken twice a day, and will require a prescription. Side effects are rare and generally mild - stomach ache, dizziness and fatigue, and are reversible, Baumel said. Baumel cautioned people with mild to moderate forms of Alzheimer's against taking memantine because clinical trials so far have not shown any benefit for them. "If you can already do those functions of daily living, you don't need it," Baumel said. "As far as memory goes, it is not that kind of a compound." The best results from the trials were in people with moderate to severe disease who took both memantine and one of the other drugs, such as Aricept, which slow progression of the disease by a different mechanism, Baumel said. "They found in that group that activities of daily living were better and there was even improvement, which translates to a better standard of living for both the person taking the medication and the person taking care of them," Baumel said. --- SOURCE: The South Florida Sun-Sentinel / The Centre Daily Times, PA http://www.centredaily.com/mld/centredaily/news/7040412.htm * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn