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FDA Panel Recommends Alzheimer's Drug's OK Memantine could be 1st drug in U.S. for later stage disease By Jamie Talan STAFF WRITER, Staff writer Randi Marshall contributed to this story. September 25, 2003 A Food and Drug Administration panel yesterday recommended approval of the Alzheimer's medicine memantine. The drug will be the first approved for patients in advanced stages of the mind-robbing disease, if the FDA accepts the recommendation. The drug has been used in Europe for more than a decade for Parkinson's disease. Last year, it was approved in Europe for Alzheimer's. It works on a different brain system than drugs currently available in this country for mild Alzheimer's. Final approval is expected within the next six weeks. "There is enough there to make a good case for this drug," said Zaven Khachaturian, senior science adviser to the Alzheimer's Association and former director of Alzheimer's research at the National Institutes of Health. "It gives physicians and family members another option for treatment. What's more, it's targeted for moderate to severe cases, and we haven't had anything to offer these patients." "This is wonderful news," said Dr. Barry Reisberg, professor of psychiatry at New York University School of Medicine and lead investigator of one of three studies used to make the case before the federal advisory panel during a hearing yesterday. Reisberg and his colleagues studied 252 patients with moderate to severe Alzheimer's disease, treating half with 20 milligrams of memantine for 28 weeks. At the end of the study, patients taking the medicine had little evidence of cognitive decline when compared with those on placebo, who continued to worsen. That study, published earlier this year in the New England Journal of Medicine, showed that the medicine slowed the normal progression of the disease by 50 percent, with fewer side effects, compared with those on a placebo. Many of the patients had progressed to the point where they could no longer pick out their clothes or put them on. They were still living in the community with support, but were in the final stage before institutionalization, Reisberg said. In his study, 80 percent on memantine were helped, with the disease process stabilized in many cases. The other two studies showed similar results, Reisberg said. However, the drug's developer, Manhattan-based Forest Laboratories, issued a news release a few months ago indicating that a study conducted to test memantine on milder symptoms found it did not have much impact at that stage of the disease. There are roughly 4.5 million Americans with Alzheimer's, a progressive dementia that robs people of their memories. In another study used to support the drug's approval, Dr. Pierre Tariot of the University of Rochester and his colleagues added memantine to the treatment plans of patients taking the medicine Aricept for at least six months. They were compared with patients on Aricept and a placebo. Those who took memantine plus Aricept showed less decline and, in some instances, some improvement compared with when they started. "If you add memantine, you get more benefit," said Dr. Steven Ferris, director of the Alzheimer's disease center at NYU's Silberstein Institute. Even though many had expected the approval, investors rallied on yesterday's decision, sending Forest's stock up $2.97, or just over 6 percent, to close at $51.70 on the New York Stock Exchange. Forest spokesman Charles Triano said the company expects to be able to market the drug within a few months of FDA approval, which could come around Oct. 19. Staff writer Randi Marshall contributed to this story. SOURCE: Newsday http://tinyurl.com/opz7 * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn