Patients suffering from mild to moderately severe Alzheimer’s disease can now receive their medication transdermally following the European Commission’s approval of Novartis’ Exelon (rivastigmine) patch.
The skin patch, which measures 10cm2 and delivers 9.5mg of the drug, is applied once daily to the patient’s back, chest or upper arm, and has similar efficacy to the highest dose Exelon capsules. It has also “been shown to increase compliance, reduce side effects and allow medication to be delivered through the skin into the bloodstream smoothly and continuously over 24 hours, helping to achieve optimal dosing”, said Dr James Shannon, Global Head of Development at Novartis Pharma.
The European go-ahead follows US approval in July, and is based on results from the international Ideal (Investigation of Transdermal Exelon in Alzheimer’s disease) study, which involved 1,200 patients with mild to moderate Alzheimer’s disease. The study compared patients on the low-dose patch with those taking the 15mg Exelon oral capsules. It found the low dose patch was just as effective as the high-dose pills but patch users reported three times fewer gastrointestinal side effects (nausea and vomiting) than pill users.
Patch gets caregivers vote
More than 70% of caregivers also preferred the patch as a method of drug delivery, as it helped them follow treatment schedules and was easier to use than oral medicine. “The patch is an important new addition to existing oral treatments options since it provides visual reassurance that patients have taken their medicine,” commented Bruno Dubois, Professor of Neurology at the Hopital Pitié Salpétrière, Centre de Neuropsychologie in Paris. “Just having to apply a patch can help reduce the burden of daily life for people with Alzheimer’s disease and their families.”
A high dose patch delivering 17.4mg was also trialled in the Ideal study. Users scored slightly better on cognition tests than pill users, with similar side effects, although Novartis says it this dose is currently being evaluated to determine whether it will pursue future filings.
Exelon patch is the first and only transdermal treatment for Alzheimer’s disease, a degenerative brain disorder affecting 18 million people worldwide and the third leading cause of death behind cardiovascular disease and cancer.