Study: Namenda Effective in Treating Mild-to-Moderate Alzheimer's

Forest Laboratories plans to seek approval later this year for its drug Namenda® (memantine HCl) after new results from a Phase III clinical trial found it to improve cognition and the overall condition of patients with mild-to-moderate Alzheimer's disease.

Dr. Lawrence Olanoff, Forest Laboratories' executive vice president, said the company would file a supplemental New Drug Application in mid-2004 for Namenda with the U.S. Food and Drug Administration as a treatment for such patients.

The trial was conducted at 42 centers and involved 403 Alzheimer's patients, evaluating the safety and effectiveness of twice daily doses of Namenda over a six-month period.

Patients receiving Namenda performed significantly better than patients receiving a placebo on the primary outcome measures of cognitive function and overall status. The drug was well tolerated and patients experienced adverse events at comparable rates to patients on a placebo.

Howard Solomon, chairman and CEO of Forest Laboratories, said the results represent an important step forward for the drug. "In the future, it is our hope that Namenda will be approved for all stages of Alzheimer's disease," he added.

Namenda is a low to moderate affinity N-methyl-D-aspartate receptor antagonist that is already approved for the treatment of moderate-to-severe Alzheimer's disease.

Other sources: Forest Laboratories