Quoted from http://www.nytimes.com/2012/03/23/business/drug-dosage-was-approved-despite-warning.html
Drug Dosage Was Approved Despite Warning
By KATIE THOMAS
Published: March 22, 2012
Four months before a best-selling Alzheimer’s drug was set to lose its patent protection, its makers received approval for a higher dosage that extended their exclusive right to sell the drug. But the higher dosage caused potentially dangerous side effects and worked only slightly better than the existing drugs, according to an article published Thursday in the British Medical Journal.
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Eisai, via Business Wire
Aricept 23 was developed by the Japanese pharmaceutical company Eisai and is marketed in the United States through a partnership with Pfizer.
They noted that the clinical trial had failed to show that the higher dosage — 23 milligrams versus the previous dosages of 5 and 10 milligrams — met its goals of improving both cognitive and overall functioning in people with moderate to severe Alzheimer’s disease.
The single clinical trial of 1,400 patients also found that the larger dosage led to substantially more nausea and vomiting, potentially dangerous side effects for elderly patients struggling with advanced Alzheimer’s disease. The drug was developed by the Japanese pharmaceutical company Eisai but is marketed in the United States in a partnership with Pfizer.