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New Data Highlight Positive Results of Namenda(R) (memantine HCl) Once-Daily Extended-Release Formulation
Date:7/30/2008

activities using the 19-item AD Cooperative Study-Activities of Daily Living scale (ADCS-ADL) demonstrated maintenance of function during the study period, but this was not significantly different from placebo (p=0.18).

The study also demonstrated that once-daily extended-release memantine was well tolerated. The treatment-emergent AEs (TEAEs) profile was similar between the groups; no TEAEs were experienced by greater than or equal to 5% of memantine patients, and at an incidence at least twice that of the placebo group. The most common adverse events occurring at a higher rate than placebo were dizziness (4.7% vs 1.5%), diarrhea (5.0% vs 3.9%), and headache (5.6% vs 5.1%).

About Alzheimer's Disease

Alzheimer's disease is a progressive, degenerative disease of the brain and the most common type of dementia. Dementia is used to describe the progressive loss of cognitive, intellectual, or functional abilities. By 2050, the number of individuals age 65 and over with Alzheimer's disease could range from 11 million to 16 million. Currently, all Alzheimer's disease medications approved in the US other than Namenda belong to a class of agents called cholinesterase inhibitors.

About Namenda

Namenda (memantine HCl) is the first in a class of medications with a unique mechanism of action that focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease. Indicated for the treatment of moderate to severe Alzheimer's disease, the FDA approved Namenda in October 2003 based on three studies of Namenda used alone or in combination with another Alzheimer's disease drug. At present, the recommended dose of Namenda is 10 mg two times a day (20 mg/day).

Namenda is contraindicated in patients with known hypersensitivity to memantine HCl or any excipients used in the formulation. The most common adverse events reported with Namenda vs placebo (greater than or equal to 5% and higher than placebo) were dizziness, confusion,
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SOURCE Forest Laboratories, Inc.
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