MONDAY, July 9 (HealthDay News) -- The U.S. Food and Drug Administration has approved a once-daily Exelon skin patch (rivastigmine transdermal system) for the treatment of mild to moderate Alzheimer disease. The cholinesterase inhibitor, made by Novartis AG, was approved in capsule form last year.
The company said the efficacy of the Exelon patch was established in IDEAL (Investigation of Transdermal Exelon in Alzheimer's Disease), an international trial of 1,200 Alzheimer disease patients. The transdermal system was well tolerated and had an efficacy similar to the highest dose of capsules.
Novartis also said the patch minimizes gastrointestinal side effects associated with the oral form of the drug.
"This new therapy is the first and only transdermal treatment for this degenerative condition affecting millions of people in the United States," according to a Novartis statement. "Exelon Patch offers effective treatment based on placebo-controlled clinical trial results showing significant benefits to patients in terms of their memory and ability to perform everyday tasks as well as helping their overall functioning."
The Exelon patch will be available in the United States soon, the company said.
More Information - Novartis
More Information - FDA
More Information - Label