By
The Associated Press
WASHINGTON - Alzheimer's sufferers are about to get a fourth medication option to help slow the worsening of the devastating brain disease.
The Food and Drug Administration approved Reminyl, a drug derived from daffodil bulbs, late Wednesday.
Manufacturer Janssen Pharmaceutica said the twice-a-day pills will be available by prescription in May, but refused to release the price.
Four million Americans suffer from Alzheimer's, which has no known cure. It afflicts mainly the elderly, robbing them of their memories and ability to care for themselves and eventually killing them.
Reminyl, known chemically as galantamine, works like the nation's three other Alzheimer's medications. It modestly slows cognitive decline by inhibiting the breakdown of acetylcholine, a brain chemical vital for nerve cells to communicate. The longer acetylcholine remains in the brain, the longer those cells can call up memories.
Reminyl had sparked intense interest when early animal research suggested it might also activate brain receptors that release chemicals like serotonin, which some scientists suspect could offer additional nerve cell protection.
But Janssen never proved that effect because it only tested Reminyl against dummy pills, not against other Alzheimer's drugs, the FDA said. "Who knows, maybe if they actually did the work they could show some advantage," said FDA drug chief Dr. Robert Temple.
Still, having another option is important, said Bill Thies, Alzheimer's Association vice president.
"We know that probably only half the people that are treated with any one of the existing compounds actually get a good result," so they need choices, he said.
One study of a small number of early-stage Alzheimer's patients found Reminyl helped some think and remember as well a year later. "I think that's pretty substantial," said Dr. Joseph Coyle of Harvard Medical School, an Alzheimer's expert who consults for Janssen - but who wants to see Reminyl directly compared to other medicines.
Like other Alzheimer's drugs, Reminyl can cause nausea, vomiting and diarrhea - hitting between 20 percent and 40 percent of patients, depending on the dose - that can cause worrisome weight loss in certain patients.
