FDA Approves Transdermal Formulation of Donepezil for Alzheimer Disease

The Food and Drug Administration (FDA) has approved a transdermal formulation of donepezil (Adlarity; Corium, Boston, MA) for treatment of mild, moderate, or severe dementia from Alzheimer disease (AD). The transdermal patch delivers 5 or 10 mg/day for 7 days. 

This formulation is expected to increase adherence to treatment by reducing the need to remember to take medication, which can be particularly challenging for people with a condition that affects memory. The formulation also reduces the gastrointestinal (GI) side effects associated with oral formulations of donepezil. 

“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and healthcare providers,” said Pierre N. Tariot, MD, director, Banner Alzheimer’s Institute. “It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” 

The most common side effects of transdermal donezepil were headache (15%), application-site pruritus (9%), muscle spasms (9%), insomnia (7%), abdominal pain (6%), application-site dermatitis (6%), constipation (6%), diarrhea (4%), application-site pain (4%), dizziness (4%), abnormal dreams (4%), and skin laceration (4%).