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Adlarity FDA Approval History

Last updated by Judith Stewart, BPharm on March 14, 2022.

FDA Approved: Yes (First approved March 11, 2022)
Brand name: Adlarity
Generic name: donepezil
Dosage form: Transdermal System
Company: Corium, Inc.
Treatment for: Alzheimer's Disease

Adlarity (donepezil transdermal system) is a once-weekly transdermal formulation of the approved acetylcholinesterase inhibitor donepezil indicated for the treatment of Alzheimer’s type dementia.

  • Alzheimer's disease is a progressive and irreversible brain disorder that involves changes in brain tissue, including abnormal buildup of proteins and loss of neuron function. It is characterized by the loss of remembering, reasoning, and thinking abilities. Donepezil works by inhibiting acetylcholinesterase to promote concentration of the neurotransmitter acetylcholine in the brain.
  • Donepezil was first approved as an oral tablet formulation under the brand name Aricept for the treatment of Alzheimer's type dementia in 1996. Oral administration of donepezil is associated with gastrointestinal side effects and fluctuations in drug plasma concentrations.
  • Adlarity is designed to deliver seven days of a consistent dose of donepezil through a patient's skin, bypassing the digestive system to reduce the possibility of gastrointestinal side effects.
  • The Adlarity transdermal system is applied to the skin once weekly.
  • Adlarity may cause serious adverse reactions including application-site skin reactions, bradycardia, nausea and vomiting, peptic ulcer disease and gastrointestinal bleeding, bladder outflow obstruction, seizures, and pulmonary conditions.
  • Common side effects include headache, application-site pruritus, muscle spasms, insomnia, abdominal pain, application-site dermatitis, constipation, diarrhea, application site pain, dizziness, abnormal dreams and skin laceration.

Development Timeline for Adlarity

Mar 14, 2022Approval  FDA Approves Adlarity (donepezil transdermal system) for Treatment of Patients with Alzheimer’s Disease
Jan 27, 2020Corium, Inc. Announces FDA Filing Acceptance of New Drug Application for Adlarity (donepezil transdermal system) for the Treatment of Alzheimer’s Disease

Further information

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