The Food and Drug Administration’s advisory committee on peripheral and central nervous system drugs yesterday narrowly recommended that the FDA approve memantine (see ARF Drugs in Clinical Trials) for advanced stages of Alzheimer’s disease. At the same time, committee members expressed concern over the small size of the therapeutic benefit seen in patients with the most severe disease. The panel evaluated data of three randomized clinical trials on late-stage patients. Memantine would be the first drug specifically approved for moderate to severe AD, as all acetylcholinesterase inhibitor drugs are approved for use in mild to moderate AD. While this step does not yet mean approval for memantine, the FDA generally follows the recommendation of its advisors; a decision is expected later this year.
Memantine has been used in Germany for 20 years, and last year received approval for the treatment of advanced Alzheimer’s throughout the European Union. It would be the first of a new class of Alzheimer's drugs, as it acts to antagonize NMDA receptors and thereby probably reduces the excitotoxic effects of excess glutamate release. This opens up the possibility of combination treatment. Preliminary survey data from Germany suggest this is safe (Hartmann and Mobius, 2003), but rigorous studies on safety and efficacy are not published yet. Memantine’s effect in mild to moderate AD is still being studied. For more information, visit the FDA’s Briefing Page on yesterday’s meeting, which contains downloadable PDFs on safety and efficacy data, and other materials.-Gabrielle Strobel.