FDA to Review Adlarity as Skin Patch Treatment for Alzheimer’s Dementia

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by Patricia Inacio PhD |

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The U.S. Food and Drug Administration (FDA) has agreed to review a new drug application (NDA) for Adlarity — Corium’s once-weekly transdermal (skin) patch delivering donepezil — to treat dementia in Alzheimer’s disease.

The FDA’s decision on whether or not to approve Adlarity is expected by July 30.

“We are thrilled with FDA’s acceptance of Corium’s NDA filing for Adlarity,” Perry J. Sternberg, president and CEO of Corium, said in a press release. “If approved, this product could represent the first once-weekly transdermal formulation of donepezil for the treatment of Alzheimer’s disease.”

Adlarity is an investigational formulation of donepezil, the same active ingredient found in Pfizer’s orally administrated Aricept (donepezil hydrochloride).

Aricept is part of a class of drugs called “cholinesterase inhibitors,” which work by inhibiting an enzyme called acetylcholinesterase. This enzyme breaks down the neurotransmitter known as acetylcholine to promote concentration of acetylcholine in the brain. This, in turn, increases the communication between remaining healthy nerve cells in the brain, and provides a temporary reprieve from dementia linked to Alzheimer’s by improving cognition and function.

Aricept is only available as oral tablets that require daily administration, and is known to cause gastrointestinal side effects.

Adlarity was designed using Corium’s proprietary Corplex technology to enable efficient delivery across the skin of small therapeutic molecules. The patch can deliver donepezil in one of two doses, 5 mg or 10 mg, through the skin every 24 hours over a one-week period. Its pharmacokinetic profile is comparable to that of oral Aricept taken daily for seven days.

Of note, pharmacokinetics refers to the movement of a compound into, through, and out of the body — the time course of its absorption, bioavailability, distribution, metabolism, and excretion.

Adlarity allows a sustained and controlled delivery of donepezil, which could help overcome variations in the active ingredient concentration in the blood. Moreover, skin absorption could help bypass the gastrointestinal side effects of Aricept and is a potential option for patients with swallowing difficulties.

“[V]ery few treatments are currently available for Alzheimer’s disease,” said Richard Isaacson, MD, director of the Alzheimer’s Prevention Clinic at Weill Cornell Medicine, who has also served on an advisory board at Corium.

“Adlarity could provide a meaningful new option for patients living with this devastating disease, as well as their caregivers,” he added.