Memantine Wins FDA Approval

The FDA last Friday followed the recommendation of its advisory panel last month (see ARF related news story) and approved memantine for use in moderate to severe AD. Forest Laboratories will sell the drug under the brand name Namenda. Though its effect on cognitive function and activities of daily living is modest, and it probably does not affect the underlying mechanisms causing the disease, memantine nevertheless is the first treatment geared toward more advanced stages of AD. For more information, see FDA press release.—Gabrielle Strobel

Comments

  1. In my opinion, the statement in the news release that memantine probably does not affect the underlying mechanisms causing the disease is actually counter to our current beliefs about the role of the NMDA receptor in the degeneration of vulnerable neurons during the early phases of the progression of the disease. I've conducted preclinical studies with memantine for the past decade and it is clearly capable of attenuating neurotoxicity related to overactivation of the NMDA receptor. The presence of beta-amyloid, hyperphosphorylated tau and neuroinflammation may underlie various aspects of the degeneration associated with AD; most theories related to the consequences of presence of these three pathological conditions have invoked a role for the activation of NMDA receptors. To the degree that these theories are true, then the long term administration of memantine should indeed alter the course of the disease. From the standpoint of basic scientist I believe that there is justification for limited optimism regarding the long term benefits of such a drug.

    View all comments by Gary Wenk

  2. I am optimistic about the introduction of memantine, and think it is more likely to affect a (if not the) basic trigger factor for onset of the disease. I plan to review results of long-term use of memantine in Germany, where I believe it has been used for some years, to see if there has been much success in its use.

    There has been a lot of emphasis on early diagnosis of Alzheimer's disease with the expectation that early intervention could provide a better chance in averting or even preventing onset of the disease.

    If basic research indicates that the NMDA receptor is involved in the pathogenesis of the disease, and early testing can indicate a person has Alzheimer's disease, there would seem to be a potential benefit for early treatment. It would be especially difficult to withhold treatment if the medicine is safe and not likely to have any bad side effects.

    This is just my initial impression, and I certainly plan further review for a more informed opinion.

    View all comments by Steven Brenner

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References

News Citations

  1. Memantine One Step Shy of US Approval

External Citations

  1. FDA press release

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