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

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