First Donepezil Transdermal Patch Approved for Alzheimer Disease | Dementia and Cognitive Impairment | JAMA | JAMA Network
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News From the Food and Drug Administration
May 3, 2022

First Donepezil Transdermal Patch Approved for Alzheimer Disease

JAMA. 2022;327(17):1642. doi:10.1001/jama.2022.6662

The first donepezil transdermal patch for treatment of mild, moderate, or severe Alzheimer disease–related dementia has been approved by the FDA.

Marketed as Adlarity, the donepezil transdermal delivery system is applied weekly to the back, thigh, or buttocks. It is available in 5-mg/d and 10-mg/d strengths, replacing oral donepezil at the same dosages. The system is designed to continuously deliver medication through the skin, maintaining a constant level needed for effective treatment. Transdermal delivery also may reduce the risk of adverse gastrointestinal effects associated with oral donepezil, according to a statement by manufacturer Corium, Inc, as well as ease administration for patients who have trouble swallowing or remembering to take a daily pill.

The donepezil transdermal delivery system was approved through FDA’s 505(b)(2) regulatory pathway, which allows developers to reference studies conducted by others rather than repeat them. Corium’s drug application included data from several clinical trials conducted by the company. According to the company news release, the transdermal system demonstrated bioequivalence to Aricept, the original oral preparation of donepezil, a cholinesterase inhibitor. Rollout is planned for early fall 2022.