The pilot BE study is a three-period, randomized crossover study comparing the steady-state pharmacokinetic (PK) profiles of once-daily oral Aricept® (donepezil hydrochloride) with two Corplex Donepezil transdermal patches that differ only in surface area. Corium reported that the steady-state PK profiles of the transdermal dosage forms measured in the second treatment period, which includes partial crossover data, continue to exhibit a close similarity with the oral PK results and were indicative of bioequivalence. The Corplex transdermal systems continued to be well tolerated, with favorable skin safety and gastrointestinal side effect profiles.
The company reported that the pilot study is on track for completion of the third and final treatment period in April and expects to report on results from the entire study in May.
The objective of the
pilot study is to enable the company to finalize key parameters, including patch surface area and number of subjects, for a successful pivotal BE study. The primary objective of the pivotal study will be the demonstration of statistically similar PK profiles between the final transdermal candidate and the oral dosage form. Corium is pursuing the BE development and regulatory pathway based on written feedback provided by the
"We are very encouraged with the positive progress in the crossover clinical study of our lead Alzheimer's program and the continued low attrition rates," said
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. An estimated 5.5 million Americans are living with Alzheimer's disease in 2017; by 2025, this number is expected to exceed 7 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.
Corium's Corplex system is a novel commercial-stage platform technology designed to broadly enable the transdermal delivery of small molecules, many of which have not previously been amenable to transdermal delivery. Corplex advanced transdermal and transmucosal systems are broadly adaptable for use in multiple drug categories and indications, and have the potential to reduce quantities of active ingredient utilized in transdermal products. Additionally, Corplex transdermal patches can enable efficient drug delivery, and adhere to either wet or dry surfaces for an extended period of time. Corium's Corplex technology has been successfully commercialized in Procter & Gamble's Crest® Whitestrips products, and is being utilized in several proprietary therapeutic products under development.
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 clinical trial and regulatory timing and plans, the achievement of clinical and commercial milestones, and the advancement of our technologies and our
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 December 31, 2016, filed with the Securities and Exchange Commission on
Corplex™ and MicroCor® are trademarks of
Aricept® is a registered trademark of
Crest® Whitestrips is a registered trademark of The Procter & Gamble Company.
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