Corium is dedicated to developing innovative therapies that continue to elevate the standards of care for the patients we serve.
AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate)
|Corplex™ Donepezil||Alzheimer’s Disease||Under New Drug Application
Corium is advancing a clinical-stage investigational product for the treatment of Alzheimer’s disease
Our lead investigational product is designed as a once-weekly treatment for Alzheimer’s disease. It is a transdermal formulation of donepezil, the active ingredient in Aricept®. Donepezil is the most commonly prescribed treatment for patients with Alzheimer’s disease.
By delivering donepezil through the skin, Corplex Donepezil is designed to avoid absorption of donepezil in the gastrointestinal (GI) tract. The product was also designed to be worn for 7 days with consistent adhesion.
We are pursuing a bioequivalence-based development and regulatory pathway for Corplex Donepezil after receiving positive written feedback on this approach from the US Food and Drug Administration (FDA) in April 2016 and September 2017.
The safety and efficacy of the products under investigation have not been established. There is no assurance that any of these investigational products will receive health authority approval or become commercially available in any country.
Corplex is a trademark of Corium, Inc. All other trademarks are the property of their respective owners.
Important potential benefits of transdermal drug delivery that could have particular relevance to people with Alzheimer’s disease and their caregivers
- Less frequent dosing due to once-weekly application
- Avoids GI metabolism, which could lead to fewer GI side effects
- Improves delivery for patients with swallowing difficulties