Forest Laboratories has voluntarily withdrawn an application filed with the U.S. Food and Drug Administration to market memantine for moderate-to-severe Alzheimer's disease.

A spokesperson for Forest said the company will refile the application, to include new efficacy and safety data from a recent phase III study of the drug, by the end of the year.

Researchers said the phase III study found that in moderate-to-severe Alzheimer's patients, memantine in combination with donepezil improved patient cognition, daily function and overall status, when compared with donepezil treatment alone.

"The recently completed trial is unique in that it is the first such rigorous study to demonstrate the ability of a treatment regimen that combines two drugs, each having a distinct mechanism of action, to offer significant benefits to Alzheimer's patients compared to treatment with an acetylcholinesterase inhibitor (donepezil) alone." said Dr. Lawrence Olanoff, Executive Vice President, Scientific Affairs of Forest.

Forest also said that in its new filing, it will correct certain structural and formatting deficiencies identified by the FDA in its previous application

Other sources: Forest