Namenda
Generic Name:
memantine HCl
Date of Approval:
October 17, 2003
Manufacturer:
Forest Laboratories Inc.
Treatment for:
moderate to severe Alzheimer's disease
--------------------------------------------------------------------------------
The U.S. Food and Drug Administration (FDA) has approved Namenda (memantine HCl) for the treatment of moderate to severe Alzheimer's disease. Namenda is the first NMDA receptor antagonist to be approved for Alzheimer's disease and is also the only therapy approved for the treatment of moderate to severe Alzheimer's disease.
Forest expects Namenda to be available to physicians, patients, and pharmacies in January 2004.
Namenda's FDA approval is based on the Agency's review of safety and efficacy data from two U.S. placebo-controlled Phase III clinical trials and an earlier trial conducted among nursing home patients in Europe. Phase III data included a 28-week monotherapy study of 252 patients published earlier this year in the New England Journal of Medicine and a six-month, 401-patient study of Namenda when used together with an ongoing regimen of the commonly used Alzheimer's agent, donepezil. In trials, patients treated with Namenda scored higher on measures of cognition, daily function, and/or global performance. This development program for memantine was a joint effort between Forest and its licensor, Merz Pharmaceuticals, who obtained centralized approval for memantine in the European Union in 2002. Merz Pharmaceuticals is a specialty pharmaceutical company dedicated to research and development in the fields of neurology and psychiatry.
In clinical trials, Namenda has been safe and well tolerated. The most common adverse events observed in clinical trials are dizziness, headache, constipation, and confusion. Once available in pharmacies, Namenda will be administered orally at a recommended dose of 10 mg BID following a four-week titration.
Alzheimer's is a progressive disease of the brain and it is the most common type of dementia. The term dementia is used to describe the progressive loss of cognitive, intellectual, or functional abilities. Published reports project that by 2010 more than 5.1 million people in the United States will have Alzheimer's disease. Currently, all Alzheimer's medications approved in the United States belong to a class of agents called acetylcholinesterase inhibitors, which are indicated for patients with mild to moderate symptoms of the disease. Namenda is the only approved therapy in the United States for moderate to severe Alzheimer's disease.
Mechanism of Action
Namenda (memantine HCl) is the first of a new class of medications for Alzheimer's disease with a mechanism of action distinct from currently available drugs. Namenda is a low to moderate affinity NMDA (N-methyl-D- aspartate) receptor antagonist. It is thought that overexcitation of NMDA receptors by the neurotransmitter glutamate may play a role in Alzheimer's disease since glutamate plays an integral role in the neural pathways associated with learning and memory. The excitotoxicity produced by abnormal levels of glutamate is thought to be responsible for neuronal cell dysfunction and the eventual cell death observed in Alzheimer's disease. Namenda is thought to selectively block the excitotoxic effects associated with abnormal transmission of glutamate, while allowing for the physiological transmission associated with normal cell functioning.
For further information, see FDA Talk Paper or visit
www.namenda.com