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US FDA approves donepezil transdermal patch for treatment of Alzheimer disease

Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced on Monday the U.S. Food and Drug Administration (FDA) has approved Corium’s Adlarity (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia of the Alzheimer’s type.

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.

Adlarity 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. Adlarity delivers seven days of a consistent dose of donepezil through a patient’s skin, maintaining the level of medicine needed for effective treatment. The transdermal delivery of donepezil directly into a patient’s skin bypasses the digestive system, resulting in a low possibility of GI side effects and making it easier for patients living with Alzheimer’s disease and their caregivers to administer the treatment reliably.

Pierre N. Tariot, MD, director of the Banner Alzheimer’s Institute in Phoenix, Ariz explained:

The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and healthcare providers. It offers effective, well-tolerated and stable dosing for seven days for patients who cannot take daily oral donepezil reliably because of impaired memory. 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.

Lori La Bey, Care Partner to her mother who lived with dementia for 30 years, Founder of Alzheimer’s Speaks, and Co-founder of Dementia Map said:

I am thrilled to hear there is a new medication for people living with Alzheimer’s disease, which uses an existing therapy with an innovative new twist. This easy-to-use skin patch offers bonuses of only needing to be administered once weekly, which in turn reduces care partners’ responsibilities too. This definitely is a step forward in the right direction.

The FDA approved the once-weekly use of Adlarity 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 Adlarity by their prescriber. Adlarity is conveniently placed by a patient or caregiver on a patient’s back, thigh, or buttocks.


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