Novartis' Alzheimer's patch shows promise in study
An international study of Novartis' Exelon patch, the first transdermal therapy for patients with Alzheimer's disease, has shown that it may provide a promising new treatment approach.
A six-month 1,195-patient trial named IDEAL showed that the Exelon patch (rivastigmine transdermal patch) provided benefits across a range of symptoms and that the target dose was well tolerated.
Patients receiving Exelon patch had significant improvements in memory and were better able to maintain everyday activities than those receiving placebo. They could also complete a concentration task 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, according to a questionnaire in the study.
"The patch may prove to be the best way to deliver rivastigmine to treat Alzheimer's disease by allowing patients to achieve good efficacy with improved tolerability," said Dr Jeffrey Cummings, professor of neurology at the University of California, Los Angeles. "The target rivastigmine patch dose provided similar efficacy to that achieved at the highest doses of the capsule with tolerability similar to placebo."
"Although Alzheimer's disease treatments have been available in oral forms for some time, we believe a patch may offer unique advantages for patients with this condition," added Dr James Shannon, global head of development at Novartis.
Exelon is a cholinesterase inhibitor already approved in many countries for the treatment of mild to moderate Alzheimer's disease and Parkinson's disease dementia. The IDEAL results will support the regulatory submission of the Exelon patch to the FDA, planned by the end of 2006.
The above article by Helen Marshall was originally published in Pharmaceutical Business Review Online, 20th July 2006
The Exelon patch was subsequently approved by the US Food and Drug Administration in 2007.
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