The launch of the medication was done in phases, as wholesalers received first-line formulary coverage in September 2022, while a nationwide launch is expected in 2023.
After receiving FDA approval in March 2022, Corium, a biopharmaceutical company, recently announced the commercial availability of its once-weekly donepezil transdermal system (Adlarity) to treat patients with mild, moderate, or severe Alzheimer disease (AD) dementia.1,2
Approved in 5 mg/day or 10 mg/day formulations, the new formulation of donepezil is delivered directly into a patient’s skin and bypasses the digestive system, resulting in a low possibility of gastrointestinal adverse effects and making it easier for patients with AD and their caregivers to administer the treatment. Donepezil, a centrally acting reversible acetylcholinesterase inhibitor, was originally approved for medical use in the US in 1996 as a generic medication.
"We are thrilled to be launching Adlarity and feel fortunate for the opportunity to provide patients living with Alzheimer's dementia, their families, and their caregivers a new, innovative way to deliver donepezil in a consistent and well-tolerated option," Perry Sternberg, president and chief executive officer, Corium, said in a statement.1 "The launch of Adlarity demonstrates the value of Corium's innovative CORPLEX technology and our commitment to providing treatment options that address unmet needs for CNS conditions. I want to thank our people, whose tireless commitment made the possibility of helping millions of people in the US living with Alzheimer disease a reality."
This new formulation of donepezil became available through wholesalers as of September 9, 2022, and has received firstline formulary coverage for patients with some commercial insurances, with more expected as the year progresses. The company expected improved patient access to the medication over time, as they continue to work with the US Centers for Medicare and Medicaid Services. As Medicare becomes available, Corium will broaden launch efforts, with a nationwide launch planned for 2023.
Donepezil transdermal system was approved pursuant to the FDA’s 505(b)(2) regulatory pathway, with data from multiple clinical trials that demonstrated bioequivalence to donepezil hydrochloride (Aricept; Eisai/Pfizer), which was approved by the FDA for treatment of severe AD in 2006. Additionally, this was the first approved product using Corium’s proprietary CORPLEX transdermal technology, which was developed to provide a sustained, continuous, controlled release of a drug over a period of time.
Although there have been no studies to indicate donepezil has a treatment effect on the disease course of AD, there was one notable 2012 study published in the New England Journal of Medicine that highlighted the cognitive benefits of the medication. In a cohort of 295 community-dwelling individuals with moderate or severe AD, those assigned to donepezil had a score on standardized Mini-Mental State Examination that was higher than those assigned to discontinue by an average of 1.9 points (95% CI, 1.3-2.5; P <.001). Additionally, those who continued treatment had Bristol Activities of Daily Living Scale that were lower (indicating less impairment) by 3.0 points (95% CI, 1.8-4.3; P <.001).3