FDA Approves Novartis's Exelon Patch
Identification Exelon is the brand name for Rivastigmine, a medication prescribed in the treatment of dementia caused by mild to moderate Alzheimer's and Parkinson's diseases.
It is the only FDA-approved drug used to treat these conditions. Exelon is manufactured by the Novartis Pharmaceuticals Corp., and can be applied as a patch, or orally, in capsule and liquid forms. In patch form, the medicine enters the body through the skin, and goes directly into the bloodstream. It works as an acetycholinesterase inhibitor to improve overall cognitive functioning
The Exelon patch is made up of four layers. An outer shell works to hold the patch together. The actual medicine portion is contained in the second layer. The third layer is the adhesive portion, while the fourth layer is a protective liner that's removed when the patch is applied. When first starting treatment, a low dosage patch containing 4.6 milligrams is applied once daily for a four-week trial period. Depending on how your body reacts to the initial dose will determine whether or not it's increased. If increased, the dosage will contain 9.5 milligrams for a 24-hour period.
As an acetycholinesterase inhibitor, the Exelon patch works to increase the amount of acetycholine--a neurotransmitter--by decreasing the amount of acetycholinerase in the brain. Acetycholinerase is responsible for breaking down acetycholine, and is produced in excess amounts when Parkinson's or Alzheimer's conditions are present. This increased amount of acetylcholine in the brain results in improved memory and awareness, as well as improvement in daily living skills.
The six-month IDEAL trial of 1,195 patients with Alzheimer's disease showed that the Exelon Patch provided benefits across a range of symptoms and the target dose was well tolerated. Results were presented today at the 10th International Conference on Alzheimer's Disease and Related Disorders (ICAD), presented by the Alzheimer's Association in Madrid, Spain.
Patients receiving Exelon Patch (rivastigmine transdermal patch) had significant improvements in memory and were better able to maintain everyday activities1 than those receiving placebo. They could also complete a concentration task up to 20 seconds faster compared to those taking placebo, and physicians considered Exelon Patch patients to have done better overall.
In addition, over 70% of caregivers in the IDEAL study preferred the patch to capsules as a method of drug delivery for reasons including helping them follow the treatment schedule, overall ease of use and less interference with daily life2, according to a questionnaire in the study.
The Exelon® Patch (rivastigmine patch) is a prescription medication approved to treat mild to moderate dementia due to Alzheimer's disease or Parkinson's disease. Although the Exelon Patch is not a cure for these diseases, it can help with some of the symptoms. The patch provides the benefits of once-daily dosing and continuous release of the medication.
The patch isn’t just for quitting smoking any more.
On Monday, the U.S. Food and Drug Administration (FDA) approved the Exelon Patch, the first skin patch for the treatment of mild to moderate Alzheimer’s disease.
The FDA also approved the Exelon Patch for the treatment of patients with mild to moderate Parkinson’s disease.