The pilot BE study was a six-month, three-period, randomized crossover study comparing the steady-state pharmacokinetic profiles of once-daily oral Aricept with two Corplex Donepezil transdermal patches that differed only in size. Corium reported that the steady-state PK profiles of the transdermal dosage forms exhibited a close similarity with the oral dosage form PK results, and that the smaller of the two patches met the statistical criteria for bioequivalence at steady-state, based on the primary PK parameters of Cmax (maximum plasma concentration) and AUC (area under the curve).
Both Corplex transdermal treatments were well tolerated, with favorable adhesion, skin safety and gastrointestinal side effect profiles after application of over 500 patches in the course of the study. For example, the incidence of nausea in subjects on the smaller patch was more than four-fold lower than the incidence of nausea with oral Aricept.
Corium is pursuing the bioequivalence-based development and regulatory pathway for Corplex Donepezil after receiving positive written feedback on this approach from the
"We are extremely pleased that our Corplex Donepezil patches
performed as well as we had projected, and that one of the tested patches actually met the regulatory bioequivalence criteria at the pilot stage. Based on these results, we can now move forward knowing that we have a product candidate that can meet the bioequivalence-based registration criteria," said
"I am encouraged by the rapid clinical development of Corium's once-weekly transdermal donepezil product," added
The pilot BE study was performed at a single trial site and enrolled 60 healthy male and female volunteers aged 20 to 78, with over 80% of the subjects over the age of 40.
The study, conducted over a period of six months, was a three-period, randomized crossover study comparing the steady-state PK profiles of once-daily oral Aricept with two Corplex Donepezil transdermal patches that differed only in size.
During each period, study participants received one week of 5mg per day of donepezil, followed by 4 weeks of 10mg per day of donepezil. PK measurements were evaluated during the fifth week of each treatment period, when plasma concentrations had achieved steady state levels. PK samples for subjects receiving the transdermal treatments were taken on a daily basis throughout this fifth week; subjects receiving oral Aricept had PK samples taken on the last day of the fifth week. There was a three-week washout period between treatment periods.
The primary objective was to enable the company to finalize key parameters for the pivotal BE study, including determination of the final patch size and the required number of subjects. The secondary objectives were assessment of safety and tolerability.
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.
Conference Call and Webcast Details
Corium will host a conference call today at 8:30 a.m. ET (
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 as well as our proprietary, co-developed and partnered 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 (SEC) on
Corplex™ and MicroCor® are trademarks of
Aricept® is a registered trademark of
Crest® Whitestrips is a registered trademark of The Procter & Gamble Company.
Investor and Media Contact:
SMP Communications Susan M. Pietropaolosusan@smpcommunications.com (201) 923-2049
News Provided by Acquire Media