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Consumer Update |
A patch that delivers medication through the skin has been approved to treat the symptoms of dementia in both Alzheimer's and Parkinson's diseases.
The Exelon Patch (rivastigmine transdermal system), approved in July 2007, provides another form of delivering the drug rivastigmine, which FDA previously approved in the form of a capsule and an oral solution. All three formulations are for use in treating mild-to-moderate dementia of people with Alzheimer's or Parkinson's disease. Dementia is a slowly worsening decline in mental abilities, such as thinking, remembering, and reasoning, that interfere with a person's daily functioning.
The patch continuously delivers medication through the skin, maintaining steady levels of the drug in the bloodstream. The patch can be applied to the back, chest, or upper arm, and should be replaced every 24 hours. It comes in two strengths: one strength delivers 4.6 mg of rivastigmine every 24 hours and the other, 9.5 mg of rivastigmine every 24 hours. An initial dose of 4.6 mg delivered every 24 hours is to be used for at least four weeks before increasing to the maintenance dose of 9.5 mg, delivered every 24 hours.
The Exelon Patch is manufactured by LTS Lohmann Therapie-Systeme AG, Andernach , Germany . It is distributed by Novartis Pharmaceuticals Corporation, East Hanover , N.J.
FDA's approval of the Exelon Patch is based on results from a large study of the patch used in people with Alzheimer's disease and several smaller studies of the Exelon capsule used in people with Alzheimer's disease and people with Parkinson's disease who had dementia. In the large study of nearly 1,200 people with mild-to-moderate Alzheimer's disease, the Exelon Patch showed effectiveness similar to that of Exelon capsules. The side effects of nausea and vomiting were lower in people treated with the patch than with the capsules.
Exelon belongs to a class of drugs called cholinesterase inhibitors, whose most common side effects include
Before using the Exelon Patch, tell your doctor if you currently have, or have a history of
Your doctor may need to monitor you more closely while you are on this medicine.
This gradually occurring brain disorder starts with mild memory loss, changes in personality and behavior, and a decline in thinking abilities (cognition). It progresses to loss of speech and movement, then total incapacitation, and eventually death. According to the National Institute on Aging, up to 4.5 million Americans suffer from Alzheimer's disease.
The main symptoms of this disorder of the nervous system affect movement and posture. However, the Exelon Patch is approved to treat only dementia, which can affect some people with Parkinson's disease.
The main symptoms of Parkinson's disease are
The features of dementia in Parkinson's disease may resemble those of Alzheimer's disease. According to the Parkinson's Action Network, more than 1 million Americans live with Parkinson's disease and 60,000 new cases are diagnosed each year. Two of five people with Parkinson's disease are estimated to have dementia.
Date Posted: August 6, 2007
