Phase 1 Study Testing Skin Patch Option for Alzheimer’s Patients Using Aricept

Transdermal (through the skin) delivery of Aricept (donepezil hydrochloride) may be as effective as the drug’s oral form, according to results of a pilot bioequivalence (BE) study conducted by Corium International.

Aricept in tablet form is one of the only drugs approved for Alzheimer’s disease in the U.S. for patients with mild to moderate dementia. The drug acts by increasing the levels of the neurotransmitter acetylcholine.

For family members and caregivers who cannot rely on Alzheimer’s patients to consistently take their medicine, taking a pill daily can pose a challenge. Also, taking Aricept orally may cause gastrointestinal side effects, including nausea, vomiting, and loss of appetite.

The three-part Phase 1 BE  study (NCT02968719) is investigating how once-weekly Corplex Donepezil transdermal patches (in two patch sizes) compares with the oral tablet in drug delivery. The primary objective is to demonstrate that the daily oral and weekly patch methods shows similar steady-state pharmacokinetic profiles (meaning that the drug in a person’s body is in equilibrium with its elimination).

According to the second of three treatment period results, the transdermal patch showed a similar profile to oral Aricept, indicating that it is bioequivalent (the rates and extent of drug absorption are the same). The skin patch is also well tolerated in patients, with no adverse effects.

The company is on track to report the full study results in May.

“We are very encouraged with the positive progress in the crossover clinical study of our lead Alzheimer’s program and the continued low attrition rates,” Peter Staple, Corium’s president and CEO, said in a news release. “With our extensive experience in successfully conducting pilot and pivotal bioequivalence studies, we are well-positioned for the upcoming pivotal BE study.”

The company plans to start a pivotal study later this year. Mr. Staple says that “we look forward to advancing this candidate towards an NDA [new drug application] filing in 2018. We believe Corplex Donepezil will provide an important new treatment option to improve the lives of Alzheimer’s patients and their caregivers.”

The Phase 1 study is expected to be completed in November 2017, and is currently recruiting patients.