A common Alzheimer’s drug is now available in skin patch form as an alternative to a daily pill.
The U.S. Food and Drug Administration approved Adlarity, a transdermal form of donepezil, this past Friday. The weekly skin patch treatment is developed and marketed by Michigan-based Corium and is an alternative to the oral, daily form of donepezil, known by the brand name Aricept first approved in 1996.
This is not the first attempt at approval for Adlarity. Corium received a complete response letter (a notice the FDA will not approve the drug) in 2020. The company later resubmitted the new drug application with new information, and it was approved on March 11.
Corium explains in a statement that the weekly patch is an alternative to the daily oral medication, allowing individuals to avoid the possibility for gastrointestinal side effects and uneven distribution of the drug.
“[Adlarity] offers effective, well-tolerated and stable dosing for seven days for patients who cannot take daily oral donepezil reliably because of impaired memory,” said Dr. Pierre N. Tariot, MD, director of Banner Alzheimer’s Institute, in the statement. “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.”
Donepezil, according to the National Center for Biotechnology Information, is a cholinesterase inhibitor. These drugs treat the symptoms of Alzheimer’s – but not the disease itself – by slowing the function of acetylcholinesterase, an enzyme which breaks down neurotransmitters called acetylcholine to increase levels of those neurotransmitters in the brain. This class of drugs is used to treat several conditions, including Alzheimer’s and other neurodegenerative diseases, and also known to cause gastrointestinal side effects when taken orally. Other cholinesterase inhibitors include rivastigmine and galantamine.
Corium expects to bring Adlarity to market in the early fall of 2022. It uses Corium’s proprietary transdermal technology called CORPLEX and is available in 5 mg/day and 10 mg/day dosage, intended for use once per week. The drug is approved to treat “mild, moderate, or severe dementia of the Alzheimer’s type,” according to Corium. According to the Centers for Disease Control, Alzheimer’s is the most common type of dementia and affects almost 6 million Americans. The risk of Alzheimer’s increases the older a person gets, and the number of Alzheimer’s patients could increase to 14 million over the next 40 years.