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FDA Reject Namenda

by Christine Kennard
for About.com

Updated: August 2, 2005

About.com Health's Disease and Condition content is reviewed by the Medical Review Board

Namenda no use in mild to moderate Alzheimer's

July 2004
The Food and Drug Administration (FDA) has declined to approve Memantine (namenda) to treat mild Alzheimer's.

The FDA currently approves Memantine (namenda) medication to treat moderate to severe Alzheimer's disease.

First given approval in 2003 Namenda has undergone three studies. Two studies failed to show any statistically significant improvement between those taking namenda and those taking a placebo. One study indicated that the medication showed promise for early Alzheimer's because drug trial participants did better in memory and thinking skills tests and showed improvement judged by their doctors and caregivers.

The Food and Drug Administration (FDA) had initially said that that the drug company, Forest Laboratories, would need just one study reaching statistical significance. However the FDA has decided not to approve Memantine (namenda) for early Alzheimer's because of the two previous studies that failed to show improvement in people with the disease.

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