With a new FDA approval, the Alzheimer’s drug found in Aricept will soon be on the market in skin patch form called Adlarity.
The FDA approves a new, transdermal form of donepezil called Adlarity, a skin patch for treating Alzheimer’s symptoms. Experts say it could be easier for some patients to deal with than the daily oral versions of the drug.
A new Alzheimer’s patch known as Adlarity has won the approval of the Food and Drug Administration (FDA). The treatment, administered once a week, delivers doses of donepezil — the most prescribed medication in a class of symptomatic Alzheimer’s medications.
Adlarity’s developer, Corium, announced in March that the FDA greenlighted the patch for treating mild, moderate or severe Alzheimer’s dementia. While an oral formulation of donepezil — a cholinesterase inhibitor (short for acetylcholinesterase inhibitor) created by the drugmaker Eisai, which partnered with Pfizer the commercialize it in the U.S. under the brand name Aricept — was first approved by the federal agency in 1996, the patch provides a different way of delivering the medication.
Banner Alzheimer’s Institute Director Dr. Pierre Tariot said the FDA’s decision to clear Adlarity is a small step forward for the Alzheimer’s community.
“It’s a reminder that relatively small-sounding advances in therapeutic options [are] resulting in more options for people, and that’s great, because this is a condition where there weren’t many options not too long ago,” Tariot, who was a paid consultant for Corium on the development of Adlarity from 2014 to 2018, told Being Patient.
When it comes to the effects of treatment, Tariot said those treated with a cholinesterase inhibitor are, on average, a year better off than patients on placebo in their cognitive and functional decline.
Who is Adlarity for?
Dr. Zaldy Tan, medical director at the Jona Goldrich Center for Alzheimer’s and Memory Disorders, noted that Adlarity could serve as a substitute for patients who benefit from donepezil tablets, but for whom taking the daily oral medication is challenging.
“The approval of an alternative way of delivering [an] acetylcholinesterase inhibitor could be helpful for a subset of patients who may not be able to tolerate oral forms of donepezil,” Tan told Being Patient. “There are patients who may have problems with swallowing or behavioral issues for whom a transdermal formulation might be helpful.”
Tariot added that the once-weekly donepezil patch, compared to the once-daily oral tablet, would make it less onerous to arrange in-home visits from a health care professional to administer the medication. So Adlarity, he said, could be an option for individuals who live alone and are unable to oversee their own medication, or for those whose care partners have trouble managing their medication.
Both Tariot and Dr. Charles Oh, Corium’s chief medical officer, added that Adlarity could be an alternative for patients who experience gastrointestinal side effects of donepezil tablets.
These side effects include nausea, vomiting, diarrhea and constipation. In a study of 60 healthy participants, Oh said gastrointestinal side effects occurred in far fewer users of the patch: roughly one out of six participants with the 10mg-per-day Adlarity patch, compared to just over half of participants with the 10mg-per-day donepezil tablet. Mild skin irritation has been reported at the site where the patch is applied.
The FDA’s regulatory pathway for approving Adlarity allowed the use of prior safety and efficacy data from the donepezil tablet, Oh noted, along with new studies conducted by Corium. All told, he said the company carried out 12 human studies, results that were submitted in the FDA application for approval, and a number of animal studies.
Currently, both Oh and Tariot are involved with preparing the manuscript of the 60-patient study for submission to a journal and presentations at conferences.
When will Adlarity be available and what will it cost?
Adlarity will be available in early fall of 2022, and final pricing has not been determined, according to Corium’s spokesperson; the company has begun the process for the Centers for Medicare & Medicaid Services to review the coverage policy for Adlarity.
According to Tariot, given that care facilities and home health agencies charge residents and those living at home, respectively, for every dose of medication, Adlarity could help reduce expenses for patients using these services.
Meanwhile, Tan anticipates that Adlarity will be much more expensive than donepezil’s oral formulations. He said this is one among many factors that he and other clinicians will consider when deciding whether to switch a patient’s prescription from donepezil tablets to Adlarity; in particular, whether the treatment’s affordability measures up to its risks and benefits for a patient will be a point of consideration.
Are there other Alzheimer’s patches?
Corium isn’t the first pharmaceutical company to seek the FDA’s approval for a donepezil patch.
In 2011, the FDA stated that Eisai and its partner Teikoku Pharma USA’s donepezil patch was not ready for approval. According to an Eisai spokesperson, Teikoku is still developing the patch, with limited support from Eisai.
When it comes to Corium’s efforts, the FDA had also rejected the company’s first application for Adlarity’s approval in 2020. But results from the 60-patient study, which had the main objective of examining the biological equivalence of Adlarity 10mg-per-day to oral donepezil 10mg-per-day, showed that the two treatments were indeed bioequivalent per the FDA’s standards, Oh said. He added that it served as the key study for the FDA’s approval of Adlarity.
In the meantime, existing patches of another cholinesterase inhibitor, known as rivastigmine, have already been on the market for years. The once-daily Exelon Patch, developed by Novartis, was first cleared by the FDA in 2007. Then, Mylan launched the generic version of Exelon in 2018, following the FDA’s approval of the company’s own patch.
The main differences between rivastigmine patches and Adlarity are the active ingredient and duration of wear, Oh noted. Currently, he added, no studies have compared rivastigmine patches against Adlarity.
All in all, treating and managing Alzheimer’s is complex, and every medication — including Adlarity — comes with potential side effects. Dr. Matthew Growdon, a geriatrician at the University of California San Francisco, urged people with Alzheimer’s and their care partners to hold thorough discussions with doctors about the different treatments available; weighing a medication’s affordability, the burdens of administering a drug, along with its risks and benefits is central to these conversations. Ultimately, he explained, a clinician’s decision for prescribing or deprescribing a treatment is made on a case-by-case basis.