Corium Presents Clinical Results from Pilot Bioequivalence Study of Corplex™ Donepezil Transdermal System at Alzheimer's As...
July 18 2017 - 7:30AM
Corium International, Inc. (Nasdaq:CORI), a commercial-stage
biopharmaceutical company focused on the development, manufacture
and commercialization of specialty transdermal products, announced
that Parminder "Bobby" Singh, Ph.D., Corium's Chief Technology
Officer and Vice President, Research and Development, today
presented the results from the company’s pilot bioequivalence (BE)
study of Corplex™ Donepezil in a poster presentation at the
Alzheimer’s Association International Conference 2017 (AAIC) in
London, UK.
Today’s poster presentation can be accessed at the Events &
Presentations section of Corium’s website here.
As announced on May 11, 2017, data from the pilot BE study
demonstrated that Corium’s Corplex Donepezil transdermal product
candidate successfully met the criteria for bioequivalence to oral
Aricept® (donepezil hydrochloride) using primary pharmacokinetic
(PK) endpoints previously established with the U.S. Food and Drug
Administration (FDA). Corplex Donepezil is a proprietary
once-weekly transdermal patch for delivery of the most commonly
prescribed treatment for all stages of Alzheimer's disease.
“These data support once-weekly Corplex Donepezil as a
bioequivalent alternative to daily Aricept,” said Dr. Singh.
“Sustained and controlled transdermal delivery of donepezil over a
seven-day period has the potential to simplify treatment, improve
patient compliance, and reduce the GI side effects common to the
oral dosage form. We look forward to bringing this convenient
therapeutic option to Alzheimer’s disease patients and their
caregivers in the near future.”
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 is planning to start its pivotal BE study later this year
and remains on track to file a Section 505(b)(2) New Drug
Application (NDA) for the product candidate in 2018. The
pivotal study will be a simpler, two-way crossover design compared
to the three-way crossover pilot study.
About Corium
Corium International, Inc. is a commercial-stage
biopharmaceutical company focused on the development, manufacture
and commercialization of specialty pharmaceutical products that
leverage the company's broad experience with advanced transdermal
and transmucosal delivery systems. Corium has multiple
proprietary programs in preclinical and clinical development,
focusing primarily on the treatment of neurological disorders, with
lead programs in Alzheimer's disease. Corium has developed
and is the sole commercial manufacturer of seven prescription drug
and consumer products with partners Mayne Pharma and Procter &
Gamble. The company has two proprietary transdermal
platforms: Corplex™ for small molecules and MicroCor®, a
biodegradable microstructure technology for small molecules and
biologics, including vaccines, peptides and proteins. In
addition to its proprietary Alzheimer’s program, the company's
late-stage pipeline includes a contraceptive patch co-developed
with Agile Therapeutics and additional transdermal products that
are being developed with other partners. For further
information, please visit www.coriumgroup.com.
Forward-Looking Statements
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 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 March 31, 2017, filed with the Securities and
Exchange Commission (SEC) on May 12, 2017, and other reports as
filed from time to time with the SEC. Undue reliance
should not be placed on forward-looking statements, especially
guidance on future financial or operating performance, which speaks
only as of the date they are made. Corium undertakes no
obligation to update publicly any forward-looking statements to
reflect new information, events or circumstances after the date
they were made or to reflect the occurrence of unanticipated
events.
Corplex™ and MicroCor® are registered trademarks of Corium
International,
Inc.
Aricept® is a registered trademark of Eisai R&D Management
Co., Ltd.
Source: Corium
Investor and Media Contact:
SMP Communications
Susan M. Pietropaolo
susan@smpcommunications.com
(201) 923-2049
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