Dedicated to innovative therapies that continue to elevate the standards of care for the patients we serve
Corium is delivering therapies that have the potential to treat conditions of the central nervous system, including Alzheimer’s disease and attention deficit hyperactivity disorder (ADHD).
Our Products & Pipeline
| PRODUCT | APPLICATION | STATUS |
| Corplex™ Donepezil | Alzheimer’s Disease | Under New Drug Application (NDA) review |
| KP415 | ADHD | Under NDA review |
Corium is advancing a clinical-stage investigational
product for the treatment of Alzheimer’s disease
Corplex Donepezil
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.
Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder in which brain cells degenerate and die, causing a steady decline in memory and mental function. An estimated 5.7 million Americans suffered from Alzheimer’s disease in 2018; and by 2050, this number is expected to approach 14 million. Alzheimer’s disease is the most common cause of dementia, and the incidence of noncompliance and swallowing issues increases as the disease progresses.
Approved for all stages of Alzheimer’s disease, donepezil tablets are the most widely prescribed medication in a class of drugs known as cholinesterase inhibitors, which are thought to work through boosting the levels of the neurotransmitter acetylcholine in the brain to impact the signs and symptoms related to memory and cognition.
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.
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
Investigational product candidate for ADHD
KP415
The FDA has accepted the NDA for the KemPharm investigational product
candidate KP415.
KP415 is the KemPharm investigational product candidate for the treatment of ADHD. It contains serdexmethylphenidate (SDX), which is the KemPharm prodrug of d-methylphenidate (d-MPH). Since SDX is a new molecular entity (NME), the FDA review guidance for NMEs is 10 months from the date of acceptance, with a target goal date under the Prescription Drug User Fee Act (PDUFA) of March 2, 2021.
Learn more about KP415 at KemPharm.com
ADHD
ADHD is a mental health disorder that can cause above-normal levels of
hyperactive and impulsive behaviors. People with ADHD may have difficulty paying attention and controlling impulsive behaviors. They may also be restless, and are almost constantly active. ADHD is not just a childhood disorder. Although the symptoms of ADHD begin in childhood, ADHD can continue through adolescence and adulthood.
Corplex is a trademark of Corium, Inc. All other trademarks are the property of their respective owners.
