The Food and Drug Administration (FDA) has approved Adlarity® (donepezil transdermal system) for the treatment of adults with mild, moderate, and severe dementia of the Alzheimer type.
Adlarity is for transdermal administration of donepezil, an acetylcholinesterase inhibitor. Each patch delivers either 5mg or 10mg of donepezil daily for 7 days, after which it is removed and a new patch is applied.
The approval of Adlarity was based on a relative bioavailability study in healthy patients comparing the transdermal system to Aricept tablets. Following administration of multiple doses in 60 healthy volunteers, donepezil exposure from once weekly Adlarity 10mg/day was comparable with that from daily donepezil tablets 10mg/day.
The adhesion of the transdermal system was evaluated in a clinical study in 85 patients, each wearing an Adlarity 10mg/day for 168 hours on the back for 4 consecutive weeks. Results showed 307 of the 338 patches (91%) exhibited 80% or greater surface area adhesion at all timepoints evaluated.
In a separate study that assessed wear at different application sites (eg, back, thigh, buttocks), findings showed that at least 85% of the patches applied at every site exhibited 80% or greater surface area adhesion for the duration of wear.
The most common adverse reactions reported with donepezil include nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia. Application-site reactions have been reported with the Adlarity patch.
The product is expected to be available in early fall 2022. Patients treated with donepezil hydrochloride 5mg/day or 10mg/day may be switched directly to Adlarity.
- Corium receives FDA approval of Adlarity® (donepezil transdermal system) for treatment of patients with Alzheimer’s disease. News release. Corium, Inc. Accessed March 14, 2022. https://apnews.com/hub/prescription-drugs
- Adlarity. Package insert. Corium, Inc.; 2022. Accessed March 14, 2022. https://www.corium.com/products/ADLARITY/ADLARITY_PI_ENGLISH_US.pdf
Source: Medical Bag https://www.medicalbag.com/home/news/donepezil-transdermal-patch-approved-for-alzheimer-disease/