Forest Laboratories, Inc. announced today that it has submitted a New Drug Application (NDA) for memantine, an investigational Alzheimer’s agent, to the U.S. Food and Drug Administration (FDA) seeking an indication for the treatment of moderate-to-severe Alzheimer’s disease. The new and amended NDA corrects minor structural and formatting deficiencies identified in a previous submission to the FDA’s Division of Neuropharmacological Drug Products. The FDA has 60 days to decide if it will accept the NDA for filing and review.
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Forest plans to amend the NDA with data from a recently completed Phase III trial by the end of January 2003. This double-blind, parallel arm, placebo-controlled study in over 400 patients showed that patients with moderate-to-severe Alzheimer’s Disease who received the combination of memantine and donepezil (Aricept(R)) performed significantly better than patients on donepezil and placebo.
In all clinical trials, memantine has been well-tolerated with adverse events, overall, comparable in incidence to that seen in patients taking placebo. Memantine is the first therapy to be considered by the FDA as a treatment for moderate-to-severe Alzheimer’s disease and is the first and only drug to show positive Phase III results when used in combination with another approved prescription product for the treatment of Alzheimer’s disease.
Alzheimer’s is a progressive disease of the brain that is the most common type of dementia. The Alzheimer’s Association projects that by 2050 more than 14 million people in the U.S. will have Alzheimer’s disease. There are currently no approved therapies in the U.S. for people who have progressed beyond the mild-to-moderate stages of the disease. In Europe, Memantine has recently been approved by the European Commission for the treatment of Alzheimer’s Disease and is available in several European countries and other selected territories of the world, under the brand AXURA (Merz) or EBIXA