CUPERTINO, Calif., Aug 26, 2002 /PRNewswire-FirstCall via COMTEX/ — DURECT
Corporation (Nasdaq: DRRX) announced today that, following discussions between
DURECT and the FDA on DURECT’s on-going Phase III clinical trial for the
CHRONOGESIC(TM) (sufentanil) Pain Therapy System, the FDA has requested that the
clinical trial protocol be amended to provide for additional patient monitoring
before enrolling additional patients in the clinical trial. This request was not
in response to any observed patient safety or adverse event.
(Photo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
In a telephone conference on Friday, August 23, 2002, the FDA requested that
DURECT put the on-going clinical trial on partial hold until the clinical trial
protocol is amended and approved by the FDA to provide for additional patient
monitoring. With respect to patients in the clinical trial who are already
implanted with the CHRONOGESIC product, DURECT is implementing increased
monitoring measures to allow such patients to continue participation in the
clinical trial. DURECT intends to submit an amendment to the existing clinical
trial protocol to provide additional monitoring measures for all patients. Upon
agreement with the FDA on the amendment, new patient enrollment in this trial
will resume.
“We believe we have had a successful start to our present Phase III clinical
trial and feel confident that we will be able to address the FDA’s requests
expeditiously,” said Dr. James E. Brown, DURECT’s Chief Executive Officer.
“Our on-going discussions with the FDA have better defined the data we will need
in order to gain approval of our CHRONOGESIC product,” said Dr. Felix Theeuwes,
Chairman and Chief Scientific Officer of DURECT. “We believe that these
amendments to the protocol of our current Phase III study will allow us to
collect the required safety and pharmacokinetic data in this early part of our
Phase III program.”
DURECT Corporation ( www.www.durect.com ) is pioneering the development and
commercialization of pharmaceutical systems for the treatment of chronic
debilitating diseases and enabling biotechnology-based pharmaceutical products.
DURECT’s goal is to deliver the right drug to the right site in the right amount
at the right time. DURECT’s lead product in development, the CHRONOGESIC(TM)
(sufentanil) Pain Therapy System is a 3-month product for the treatment of
chronic pain. DURECT owns three proprietary drug delivery platform technologies,
including the SABER(TM) Delivery System (a patented and versatile depot
injectable useful for protein delivery), the MICRODUR(TM) Biodegradable
Microparticulates (microspheres injectable system) and the DURIN(TM)
Biodegradable Implant (drug-loaded implant system).
NOTE: CHRONOGESIC(TM) is a trademark of DURECT Corporation. SABER(TM),
MICRODUR(TM) and DURIN(TM) are trademarks of Southern BioSystems, Inc., a wholly
owned subsidiary of DURECT Corporation. Other trademarks referred to belong to
their respective owners.
The statements in this press release regarding DURECT’s products in development,
expected product benefits, product development and clinical trials plans and
projected future financial results, are forward-looking statements involving
risks and uncertainties that can cause actual results to differ materially from
those in such forward-looking statements. Potential risks and uncertainties
include, but are not limited to, DURECT’s ability to research, develop,
manufacture and commercialize its products, obtain product and manufacturing
approvals from regulatory agencies, timely enroll patients and clinical sites in
connection with its clinical studies, effectively administer its clinical
trials, manage its growth and expenses, finance its activities and operations,
as well as marketplace acceptance of DURECT’s products. Further information
regarding these and other risks is included in DURECT’s Annual Report on Form
10-K for the fiscal year ended December 31, 2001 filed with the SEC on March 28,
2002, under the heading “Factors that may affect future results,” and other
periodic reports filed with the SEC. CHRONOGESIC is under development by DURECT
and has not been submitted or approved for commercialization by the US Food and
Drug Administration or other health authorities.
SOURCE DURECT Corporation
CONTACT:
Schond L. Greenway, Senior Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417,
schond.greenway@durect.com
URL:
http://www.www.durect.com
Copyright (C) 2002 PR Newswire. All rights reserved.