Namenda XR approved for dementia of the Alzheimer's type

The FDA has approved Namenda XR, an extended-release formulation of memantine HCl, for the treatment of moderate to severe dementia of the Alzheimer's type. This approval was based on clinical data from a randomized, double-blind, placebo-controlled trial of 677 patients already receiving a cholinesterase inhibitor. Study results indicate that patients treated with Namenda XR experienced statistically significant benefits in cognition and clinical global status compared to placebo.

Namenda XR is expected to be made available in a 28mg dosage strength.

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