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FDA Approves Donepezil Transdermal Patch for Alzheimer Disease
The US Food and Drug Administration has approved Adlarity® (donepezil transdermal system) for release in the fall of 2022. Adlarity is indicated in the treatment of adults with Alzeheimer-type mild to severe dementia symptoms.
Adlarity is a 7-day patch that delivers continuous, consistent doses of donepezil through the skin, and is available in 5- and 10-mg/d strengths. The use of the CORPLEXTM transdermal technology lessens the gastrointestinal (GI) side effects noted in oral consumption of donepezil and assists both patients and caregivers in administering more reliable treatment.
“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers. 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,” said Pierre N. Tariot, MD, director of the Banner Alzheimer’s Institute in Phoenix, Arizona, in a news release.
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Recent study results have shown greater than 80% surface area adhesion was reached in 91% of participants at all tested time points when the donepezil patch was applied to their back. A separate study also showed the same amount of surface area adhesion (80%) was achieved in at least 85% of participants who applied the donepezil patch in different areas (eg, back, thigh, buttocks). Finally, in a bioavailability study of 60 healthy volunteers, the transdermal system received comparable donepezil exposure when tested against the oral medication therapy in the 10-mg/d dosage.
“I am thrilled to hear there is a new medication for people living with Alzheimer disease, which uses an existing therapy with an innovative new twist. This easy-to-use skin patch offers bonuses of only needing to be administered once-weekly, which in turn reduces care partners' responsibilities too. This definitely is a step forward in the right direction,” said Lori La Bey, Care Partner to her mother who lived with dementia for 30 years, founder of Alzheimer's Speaks, and co-founder of Dementia Map, in a news release.
Adlarity is contraindicated for patients with a sensitivity or allergy to donepezil or piperidine derivatives or with a history of allergic contact dermatitis.
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