FDA Approves Donepezil Transdermal Patch for Treatment of Alzheimer Disease

The FDA has approved donepezil transdermal system (Adlarity, Corium) as treatment for individuals with mild, moderate, or severe Alzheimer disease (AD).

The donepezil transdermal system is the first and only once-a-week patch to continuously deliver consistent doses of donepezil through the skin, which results in a lower likelihood of adverse gastrointestinal events that are normally associated with oral donepezil.

Additionally, the donepezil transdermal system is the first approved prescription drug with Corium’s Corplex transdermal technology, which has been used in consumer products for years.

“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,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute in Phoenix, Arizona, said in a 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,” he said.

Donepezil is the most prescribed medication among the acetylcholinesterase inhibitors for AD treatment and has the same active ingredient as Arcept (Eisai, Pfizer), the oral medication.

Oral donepezil goes through an individual’s digestive system, which can lead to GI adverse effects (AEs) and fluctuations in the concentration of drug in circulation. However, the transdermal patch delivers 7 days of a consistent dose of donepezil through an individual’s skin, so it bypasses the digestive system and results in a low possibility of GI AEs.

The most common AEs were abdominal pain, application-site dermatitis, application-site pain, constipation, diarrhea, dizziness, headaches, insomnia, and muscle spasms.

“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 Sternberg, president and CEO of Corium, said in a statement.

The FDA approved the transdermal patches in the 5- and 10-mg/day formulations. Individuals may be switched from 5 or 10 mg/day oral donepezil directly to the transdermal patches by their prescriber.

Individuals can place the patches on the back, buttock, or thigh.

The drug will be available in early fall 2022 and was approved in the FDA’s 505(b)(2) regulatory pathway and demonstrated bioequivalence to the oral version of the drug. The FDA decision was determined by data from several clinical trials conducted by Corium.

It is also the second central nervous system (CNS) product approval and the second CNS product that Corium will commercialize within 12 months.

In July 2021, Corium launched serdexmethylphenidate and dexmethylphenidate (Azstarys) for the treatment of attention-deficit/hyperactivity disorder in individuals aged 6 years and older, following the FDA approval in March 2021.

Reference

Corium receives FDA approval of ADLARITY (donepezil transdermal system) for treatment of patients with Alzheimer’s Disease. Corium. News release. March 14, 2022. Accessed March 15, 2022. Email.