Forest Laboratories, Inc. and Merz Pharmaceuticals GmbH announced that Namenda XR (memantine hydrochloride) was approved by the US 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 US 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.
Namenda XR (memantine HCl) extended release capsules are a 28mg once-daily formulation of Namenda approved for the treatment of moderate to severe dementia of the Alzheimer's type. Namenda , a twice daily immediate release formulation, was approved in October 2003. Namenda XR has a mechanism of action that focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease.
Merz Pharmaceuticals researches, develops, produces and distributes innovative pharmaceutical products in the areas of neurology and psychiatry as well as in aesthetic dermatology and metabolism.
Forest Laboratories is a US-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives.