FDA approval of Adalarity transdermal system for treatment of patients with Alzheimer's disease.

The FDA approved the once-weekly use of Adalarity in 5 mg/day or 10 mg/day formulations. Patients may be switched from 5 mg/day or 10 mg/day oral donepezil directly to the once-weekly Adalarity by their prescriber. Adalarity is conveniently placed by a patient or caregiver on a patient’s back, thigh, or buttocks.

Adalarity will be available in early fall 2022. Adlarity was approved pursuant to FDA’s 505(b)(2) regulatory pathway and demonstrated bioequivalence to Aricept. Corium’s drug application included data from several clinical trials conducted by the company

Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood of adverse gastrointestinal (GI) side effects associated with oral donepezil.

The availability of a once-weekly patch form Adalarity is the first approved prescription drug product using Corium’s proprietary CORPLEX transdermal technology, which has been used for years in consumer products. Donepezil is the most prescribed medication in a class of Alzheimer's drugs known as acetylcholinesterase inhibitors and is the active ingredient in the oral medication Aricept. Oral donepezil is absorbed through a patient’s digestive system, a route associated with GI side effects and fluctuations in the concentration of drug in circulation. Adalarity delivers seven days of a consistent dose of donepezil through a patient’s skin, maintaining the level of medicine needed for effective treatment.