FDA Approves New Delivery Method for Alzheimer’s Disease

Adlarity delivers donepezil to patients using a skin patch, lowering the risk of gastrointestinal adverse events. It will be available in early fall 2022.

The FDA has approved Corium’s Adlarity (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia related to Alzheimer’s disease. Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood of adverse gastrointestinal side effects associated with oral donepezil. Adlarity will be available in early fall 2022.

Donepezil is the most prescribed medication in a class of Alzheimer's drugs and is the active ingredient in the oral medication Aricept. Adlarity delivers a consistent dose of donepezil through a patient’s skin over seven days.

“The FDA approval of Adlarity brings to market a new and innovative way to deliver

consistently a well-tolerated form of donepezil, the most widely used medicine for patients

with Alzheimer’s disease,” Perry J. Sternberg, president and CEO of Corium, said in a press release.

Adlarity is the first approved prescription drug product using Corium’s proprietary Corplex transdermal technology. The platform allows for transdermal delivery of small molecule drugs thought to be incapable of being delivered through the skin.

It is the same technology used in Corium’s partner’s Procter & Gamble’s Crest Whitestrips product. The technology has also been used in other forms, including liquid (sprays, film formers), semisolid (gel, creams and ointment-like), and solid (powder, particles, dry and wet films, and patches).

Alzheimer’s disease is a progressive and irreversible brain disorder. It involves changes in brain tissue including abnormal buildup of proteins as well as loss of neuron function. This can lead to the loss of remembering, reasoning, and thinking abilities.

An estimated 6.2 million Americans were living with Alzheimer’s disease in 2021, with a possible rise to 13.8 million by 2060.