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Forest Laboratories, Inc. announced today that NAMENDA XR
(TM) (memantine hydrochloride) once-daily formulation is now available in pharmacies throughout the United States. NAMENDA XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe dementia of the Alzheimer’s type.
New NAMENDA XR 28 mg is a higher dose, once-daily extended-release formulation of NAMENDA (memantine) immediate-release. The efficacy and safety of NAMENDA XR was established in a randomized, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of acetylcholinesterase inhibitors (AChEl). AChEIs are a different class of prescription drugs often used in combination with NAMENDA for the treatment of moderate to severe Alzheimer’s disease. The results of this study, demonstrated statistically significant improvement in cognition and global function for patients treated with NAMENDA XR 28 mg plus an AChEI compared to placebo plus an AChEI. Cognition was measured by the Severe Impairment Battery (2.6 unit mean difference). Global function was measured by the Clinician’s Interview-Based Impression of Change (0.3. unit mean difference). NAMENDA XR was studied in combination with commonly prescribed AChEIs (donepezil, galantamine, or rivastigmine). Namenda XR can be used alone or added to other acetylcholinesterase inhibitors The most commonly observed adverse reactions seen in patients administered NAMENDA XR (28 mg/day) in a controlled clinical trial, defined as those occurring at a frequency of at least 5% in the NAMENDA XR group and at a higher frequency than placebo were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).
“We are pleased to be introducing NAMENDA XR so that patients can benefit from the convenience of a once-daily regimen that aligns with once-daily AChEIs,” said Dr. Marco Taglietti, President Forest Research Institute. “The NAMENDA XR study supports the existing body of evidence that memantine provides cognitive and global benefits in patients with moderate to severe Alzheimer’s disease either alone or with an AChEI.”