Mementine

Memantine Update FDA Advisory Committee Meet on Memantine

Memantine, an investigational Alzheimer drug that acts with a different biochemical mechanism than the drugs currently approved specifically to treat Alzheimer symptoms, will be the subject of a public meeting of the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) September 24, 2003, in Bethesda, Maryland.

Under discussion will be the application that Forest Laboratories, memantine's U.S. developer, submitted in December 2002 for approval of memantine distribution in the U.S. to treat symptoms of moderate to severe Alzheimer's disease.

Memantine differs from other drugs currently available in the U.S., all of which are in the pharmacological class of cholinesterase inhibitors and are approved for mild to moderate Alzheimer's disease.

Although the FDA is under no legal obligation to accept guidance from advisory committees, the agency often follows their recommendations. Advisory committees provide independent, expert scientific and medical advice to the FDA on the safety, effectiveness, and appropriate use of products under its jurisdiction.

For more information, please see:

• FDA's advisory committee meeting announcement http://www.fda.gov/oc/advisory/accalendar/cder12543dd09242503.html

• The Alzheimer's Association memantine fact sheet. http://www.alz.org/ResourceCenter/ByTopic/memantine.htm

• Previous Research News features from June 19, 2003, (link to http://www.alz.org/WhatsNew/memantinetherapytrial.htm), April 24, 2003, link to http://www.alz.org/WhatsNew/neramexane.htm), April 8, 2003 (link to http://www.alz.org/WhatsNew/combinationtrial.htm), a second feature on April 8, (link to http://www.alz.org/WhatsNew/memantinereport.htm), April 3, (link to http://www.alz.org/WhatsNew/memantinestudy.htm),and January, 30, 2003. (link to http://www.alz.org/WhatsNew/memantine.htm)