Corium Presents Additional Positive Clinical Results at Alzheimer's Association International Conference® 2018
Today's poster presentation can be accessed at the Events & Presentations section of Corium's website here.
Corium had previously reported positive PK bioequivalence data comparing once-weekly Corplex Donepezil and daily oral Aricept at steady state. In the poster results presented today, these bioequivalence results were further supported by equivalent pharmacodynamics of Corplex Donepezil and oral Aricept, characterized by the relationship between plasma donepezil concentrations and red blood cell acetylcholinesterase inhibition, which is an important biomarker of the pharmacodynamic response to donepezil.
The results also demonstrated that donepezil exposure over the 7-day wear duration was dose proportional for the two intended product strengths, 5 mg/day and 10 mg/day. Further, the pharmacokinetics were independent of age, indicating no dose adjustment is required for Corplex Donepezil based on age.
"The close match of the pharmacodynamic response for bioequivalent oral and transdermal regimens further supports therapeutic equivalence between Aricept and Corplex Donepezil," said Dr. Singh. "We remain on track to file a 505(b)(2) New Drug Application (NDA) for the product candidate in early 2019 and look forward to bringing this important new therapeutic option to Alzheimer's disease patients and their caregivers in the near future."
The bioequivalence study was a six-month, three-period, randomized crossover study comparing the steady-state PKPD profiles of once-daily oral Aricept with Corplex Donepezil.
Corplex Donepezil is a proprietary once-weekly transdermal patch for delivery of the most commonly prescribed treatment for all stages of Alzheimer's disease.
About Alzheimer's Disease and Donepezil
Alzheimer's disease is a progressive brain disorder in which the brain cells degenerate and die, causing a steady decline in memory and mental function. According to the Alzheimer’s Association, an estimated 5.7 million Americans are living with Alzheimer's disease in 2018; by 2050, this number is projected to rise to 13.8 million. Alzheimer's disease is the most common cause of dementia among older adults. Dementia ranges in severity from mild, when it is just beginning to affect a person's functioning, to moderate, and severe, when the person must depend on others for the basic activities of day-to-day life.
Donepezil (the active ingredient in Aricept®) is the most widely prescribed medication in a class of Alzheimer's drugs known as cholinesterase inhibitors, and is approved for the treatment of mild, moderate and severe disease. Donepezil is currently only available in tablet or orally disintegrating tablet form, each administered once daily, presenting compliance challenges for family members and caregivers who cannot rely on patients to consistently take their daily tablets, and is known to cause gastrointestinal side effects, including nausea, vomiting and loss of appetite.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding our products, intellectual property rights and portfolio, regulatory pathway, timing and plans, and the advancement of our technologies, proprietary products and product candidates. Forward-looking statements are based on management's current expectations and projections and are subject to risks and uncertainties, which may cause Corium's actual results to differ materially from the statements contained herein. Further information on potential risk factors that could affect Corium's business and its results are detailed in Corium's Quarterly Report on Form 10-Q for the quarter ended
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Source: Corium International, Inc.