Comparison of Weekly Skin Patch vs Daily Pill Used for Treatment of People with Alzheimer’s Disease
What is it about?
Donepezil is approved by the United States Food and Drug Administration for the treatment of dementia of the Alzheimer type and has only been available in pill form administered orally once daily. Initiating or increasing the dose of oral donepezil can result in gastrointestinal problems, such as nausea, diarrhea, and vomiting, which causes patients to discontinue using donepezil. A once-weekly donepezil skin patch, a donepezil transdermal delivery system (TDS), may offer several benefits compared with a once-daily tablet, including reducing gastrointestinal side effects and improving ease-of-use. This study compared the pharmacokinetics of once-weekly 10-mg/d and dose-normalized 5-mg/d donepezil TDSs with once-daily 10-mg oral donepezil in healthy volunteer participants to determine if the donepezil TDSs are bioequivalent to oral donepezil. Side effects of these treatments, and skin reaction and skin adhesion of the TDSs were also monitored.
Why is it important?
The study showed that once-weekly 10-mg/d and dose-normalized 5-mg/d donepezil TDS are bioequivalent to once-daily 10-mg oral donepezil. Donepezil TDSs were associated with fewer gastrointestinal disorders than oral donepezil. Participants using donepezil TDS also had fewer side effects related to the central nervous system, such as dizziness and sleepiness. For donepezil TDS, skin itchiness and inflammation were reported at the TDS site, but these skin problems were mild, and none of the participants removed their TDSs for these reasons. Both TDSs remained adherent to skin during the 1-week wear period, and skin adhesion was similar for both TDSs. The results support using donepezil TDS as a once-weekly dosing regimen to treat dementia of the Alzheimer type.