FDA to Review Donepezil Transdermal System for Alzheimer Disease

A PDUFA target date of June 30, 2020 has been assigned to the application.

The Food and Drug Administration has accepted for filing the New Drug Application (NDA) for Adlarity (donepezil transdermal system; Corium) for the treatment of dementia of the Alzheimer type in patients with mild, moderate, and severe Alzheimer disease.

Adlarity is an investigational, once-weekly transdermal formulation of donepezil that is designed to be worn for 7 days with consistent adhesion. Administration of donepezil via a transdermal patch could potentially reduce plasma level fluctuations and gastrointestinal side effects, as first pass effects would be avoided. Moreover, this type of delivery method would provide an alternative treatment option for patients with swallowing difficulties.

The Adlarity NDA includes data from a randomized crossover study comparing the steady-state pharmacokinetic profiles of the 5mg/day and 10mg/day transdermal patches with once-daily oral donepezil. Corium is seeking approval through the 505(b)(2) regulatory pathway, an abbreviated approval pathway that allows for some of the information required for approval to come from studies related to donepezil. 

A Prescription Drug User Fee Act (PDUFA) target date of June 30, 2020 has been assigned to the application.

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Currently, donepezil, a reversible acetylcholinesterase inhibitor, is available in tablet and orally-disintegrating tablet formulations.

For more information visit coriumintl.com.