The Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act target date of March 11, 2022 for the New Drug Application for Adlarity (donepezil transdermal system) for the treatment of patients with dementia due to mild, moderate, and severe Alzheimer disease.
Adlarity is a 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 application was initially accepted for filing by the FDA under the 505(b)(2) regulatory pathway (referencing Aricept data) in January 2020. It was then resubmitted with additional data from 3 clinical trials addressing questions posed by the Agency in a Complete Response Letter.
Corium is seeking approval of 2 dosage strengths of the patch expected to deliver 5 or 10mg of donepezil daily.
Corium receives March 11, 2022 PDUFA date for New Drug Application for Adlarity® patch (donepezil transdermal system) for treatment of patients with Alzheimer’s disease. News release. Corium, Inc. Accessed October 12, 2021. https://www.prnewswire.com/news-releases/corium-receives-march-11-2022-pdufa-date-for-new-drug-application-for-adlarity-patch-donepezil-transdermal-system-for-treatment-of-patients-with-alzheimers-disease-301397264.html.
Source: Medical Bag https://www.medicalbag.com/home/news/fda-assigns-pdufa-date-for-donepezil-transdermal-system/