Forest Laboratories, Inc. and Merz Pharmaceuticals GmbH announced today that NAMENDA XR(TM) (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer’s type. NAMENDA XR is a 28 mg once-daily extended-release formulation of NAMENDA. The safety and efficacy of NAMENDA XR were established in a randomized, double-blind, placebo-controlled trial of 677 outpatients already taking a cholinesterase inhibitor. The results indicate that patients treated with NAMENDA XR experienced statistically significant benefits in cognition and clinical global status compared to placebo.
NAMENDA XR will be covered by U.S. Patent No. 5,061,703, which is listed in the Orange Book for NAMENDA and expires in April 2015. In addition, Forest owns pending patent applications related to NAMENDA XR. The companies are determining the appropriate commercialization strategy and market timing to ensure a successful franchise.