namenda fact sheet

Date of Approval:
October 17, 2003

Manufacturer:
Forest Laboratories Inc.

Treatment for:
moderate to severe Alzheimer's disease

The U.S namenda fact sheet. Food and Drug Administration (FDA) has approved Namenda (memantineHCl) for the treatment of moderate to severe Alzheimer's disease namenda fact sheet. Namenda isthe first NMDA receptor antagonist to be approved for Alzheimer's disease andis also the only therapy approved for the treatment of moderate to severe Alzheimer'sdisease.
Forest expects Namenda to be available to physicians, patients, and pharmaciesin January 2004.

Namenda's FDA approval is based on the Agency's review of safety and efficacydata from two U.S namenda fact sheet. placebo-controlled Phase III clinical trials and an earliertrial conducted among nursing home patients in Europe namenda fact sheet. Phase III data includeda 28-week monotherapy study of 252 patients published earlier this year in theNew England Journal of Medicine and a six-month, 401-patient study of Namendawhen used together with an ongoing regimen of the commonly used Alzheimer'sagent, donepezil namenda fact sheet. In trials, patients treated with Namenda scored higher onmeasures of cognition, daily function, and/or global performance namenda fact sheet. This developmentprogram for memantine was a joint effort between Forest and its licensor, MerzPharmaceuticals, who obtained centralized approval for memantine in the EuropeanUnion in 2002 namenda fact sheet. Merz Pharmaceuticals is a specialty pharmaceutical company dedicatedto research and development in the fields of neurology and psychiatry.

In clinical trials, Namenda has been safe and well tolerated namenda fact sheet. The most commonadverse events observed in clinical trials are dizziness, headache, constipation,and confusion namenda fact sheet. Once available in pharmacies, Namenda will be administered orallyat 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 commontype of dementia namenda fact sheet. The term dementia is used to describe the progressive lossof cognitive, intellectual, or functional abilities namenda fact sheet. Published reports projectthat by 2010 more than 5.1 million people in the United States will have Alzheimer'sdisease namenda fact sheet. Currently, all Alzheimer's medications approved in the United Statesbelong to a class of agents called acetylcholinesterase inhibitors, which areindicated for patients with mild to moderate symptoms of the disease namenda fact sheet. Namendais the only approved therapy in the United States for moderate to severe Alzheimer'sdisease.

Mechanism of Action

Namenda (memantine HCl) is the first of a new class of medications for Alzheimer'sdisease with a mechanism of action distinct from currently available drugs namenda fact sheet. Namenda is a low to moderate affinity NMDA (N-methyl-D- aspartate) receptorantagonist namenda fact sheet. It is thought that overexcitation of NMDA receptors by the neurotransmitterglutamate may play a role in Alzheimer's disease since glutamate plays an integralrole in the neural pathways associated with learning and memory namenda fact sheet. The excitotoxicityproduced by abnormal levels of glutamate is thought to be responsible for neuronalcell dysfunction and the eventual cell death observed in Alzheimer's disease namenda fact sheet. Namenda is thought to selectively block the excitotoxic effects associated withabnormal transmission of glutamate, while allowing for the physiological transmissionassociated with normal cell functioning.

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