Forest Laboratories, Inc. announced it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) to market memantine for the treatment of moderate-to-severe Alzheimer's disease.

Several studies have suggested that memantine not only appears to improve memory in patients with moderate-to-severe Alzheimer's, but provides a variety of daily living and functioning benefits for patients and time savings and cost benefits for their caregivers (see earlier Alzheimer Week story).

Currently, there are no approved medications for people who have progressed beyond the mild-to-moderate symptoms of the disease.

"We believe that memantine can be a very useful drug in the treatment of this serious disease," said Howard Solomon, Chairman and Chief Executive of Forest.

He said it was possible, however, that the FDA may not act on the application which is based on two clinical trials, one conducted in the United States and one in Europe.

"Tthe clinical trial conducted in Europe did not include one of the endpoints the agency has historically required for evaluation of treatments for mild-to-moderate Alzheimer's Disease," Solomon said. "Forest is presently conducting four additional placebo-controlled studies in either mild-to-moderate or moderate-to-severe Alzheimer's disease with the earliest results expected in 2003."

Other sources: Forest Laboratories