News - Alzheimer Weeks of Dec. 22 & 29, 2002 / Vol. 2 No. 51


Forest Resubmits Application for Memantine to FDA

 

Forest Laboratories Inc. has resubmitted its application to the U.S. Food and Drug Administration for approval of memantine, a proposed treatment for Alzheimer’s disease.

The company withdrew the application in September after the FDA requested that deficiencies be remedied (see earlier Alzheimer Week story).

A spokesperson for Forest said the company planned to add final data by the end of January from a Phase III trial, which has produced positive preliminary results in treating moderate to severe Alzheimer's.

Dr. Pierre Tariot, a University of Rochester professor who oversaw the trial, said Alzheimer’s patients who received a combination of memantine and donepezil performed significantly better than those who got donepezil and a placebo.

Those getting the memantine combination also showed less decline in activities associated with daily living.

Donepezil, sold under the name Aricept, currently is given alone to many patients with mild to moderate forms of Alzheimer’s.

“At the end of the six months, those who took the combination were performing better than when they started the drugs,” said Tariot. "The combination of drugs is clearly superior."

Other sources: Forest, Rochester Democrat and Chronicle