FDA rejects memantine for mild Alzheimer's
The U.S. Food and Drug Administration (FDA) declined to approve memantine (Namenda) to treat mild Alzheimer's disease, Forest Laboratories announced today.
Memantine was approved to treat moderate to severe Alzheimer stages in 2003.
Forest has conducted three studies of memantine as a treatment for mild to moderate Alzheimer's. In one study, participants taking memantine fared better than those receiving a placebo on tests of memory and thinking skills as well as on assessments by their physicians and caregivers. In two other studies, memantine failed to show any statistically significant benefit compared with the placebo. In one of the studies that failed to show benefit, participants were already on a stable dose of a cholinesterase inhibitor at the time they began taking memantine.
For more information, please see:
- Alzheimer's Association fact sheet on memantine
- Forest Laboratories press release about FDA's rejection of memantine for mild Alzheimer's disease
- A Medscape news article on the study in mild Alzheimer's disease that found a statistically significant benefit for memantine
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