DURECT Initiates Phase I Trial for Its Proprietary Transdermal Sufentanil Patch

Download PDF:

              Patch to be Highlighted at ASA 2004 Annual Meeting

CUPERTINO, Calif., Oct. 22 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) today announced the initiation of a phase I clinical trial for
a new proprietary transdermal sufentanil product. The trial consists of a
pharmacokinetic study in normal, healthy volunteers in Europe. The objectives
of the clinical study are to determine the safety and tolerability of DURECT’s
transdermal sufentanil patch as well as evaluate the pharmacokinetics of
sufentanil following transdermal administration. Sufentanil is a pain relief
medication that is currently FDA-approved for use in hospitals as an analgesic
and is the active ingredient in DURECT’s CHRONOGESIC(R) product under
development. DURECT’s transdermal sufentanil product is intended to provide
extended chronic pain relief for up to seven days, as compared to the three
days of relief provided with currently available patches. Further, DURECT
anticipates that the small size of the DURECT sufentanil patch (approximately
1/5th the size of current transdermal fentanyl patches for a therapeutically
equivalent dose) may offer improved convenience for patients. Worldwide sales
for DURAGESIC(R), a leading transdermal fentanyl product, exceeded
$1.6 billion in 2003.

(Photo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )

Transdermal Sufentanil Patch Product Description

DURECT’s sufentanil transdermal patch product potentially offers the
following benefits over current transdermal fentanyl patches:

  • Increased duration of pain relief for up to seven days
  • Smaller patch size (approximately 1/5th the size of current transdermal
    fentanyl patches for a therapeutically equivalent dose)
  • We anticipate that other potential benefits could be:
  • Improved convenience and patient compliance
  • Reduced skin irritation
  • Cosmetic and quality of life improvements
  • Improved patch adhesion
  • Easier for high dose patients who require multiple transdermal

“In our Phase II study for our CHRONOGESIC product, where sufentanil is
the active ingredient, the data showed 2-to-1 patient preference for the
therapy, better pain control and an improved side effect profile when compared
to other opioid medications on the market. We anticipate that some of these
benefits will also be applicable to our transdermal sufentanil product,”
stated James E. Brown, DVM, President and CEO of DURECT. “We are leveraging
the knowledge and infrastructure relating to sufentanil gained from our
considerable work with this compound to the development of our transdermal
product. We believe that our transdermal product will be additive and
complementary to DURECT’s other pain-related products currently under

American Society of Anesthesiologists (ASA) 2004 Annual Meeting

Pamela Palmer, M.D., Ph.D., Professor, Department of Anesthesiology and
Peri-Operative Care, and Medical Director of the Pain Management Center at
University of California, San Francisco (UCSF), will be delivering a
presentation discussing several innovative approaches to pain management at
this weekend’s ASA meeting in Las Vegas, Nevada. The presentation, entitled
“Pharmacologic Approaches to Pain Management,” will highlight details of
DURECT’s transdermal sufentanil patch and will be made on Saturday, October
23, 2004 at 8:30 a.m. in rooms N115-116 at the Las Vegas Convention Center.

About DURECT Corporation

DURECT Corporation is a pharmaceutical company focused on the development
of pharmaceutical systems based on its proprietary drug delivery platform
technologies that treat chronic debilitating diseases and enable biotechnology
products. These platform technologies include the SABER(TM) Delivery System (a
patented and versatile depot injectable useful for protein and small molecule
delivery), the ORADUR(TM) sustained release oral gel-cap technology (an oral
sustained release technology with several potential abuse deterrent
properties), the DURING(TM) Biodegradable Implant (drug-loaded implant system)
and the MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable
system). DURECT also partners with pharmaceutical companies to develop and
commercialize proprietary and enhanced pharmaceutical products based on its
technologies. DURECT has five disclosed on-going development programs of which
three are in collaboration with pharmaceutical partners. Additional
information about DURECT is available at www.www.durect.com.

are trademarks of DURECT Corporation. Other referenced trademarks belong to
their respective owners.

The statements in this press release regarding DURECT’s products in
development, product development plans, anticipated clinical trials and
potential markets 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 complete the design, development,
and manufacturing process development of these products, manufacture and
commercialize these products, obtain product and manufacturing approvals from
regulatory agencies as well as marketplace acceptance of these 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, 2003 filed
with the SEC on March 11, 2004, DURECT’s Quarterly Report on Form 10-Q and
other periodic reports filed with the SEC under the heading “Factors that may
affect future results.”

The transdermal sufentanil patch and CHRONOGESIC(R) products referred to
in this press release are under development and have not been submitted or
approved for commercialization by the US Food and Drug Administration or other
health authorities.


/CONTACT: Schond L. Greenway, Executive Director, Investor Relations and
Strategic Planning, of DURECT Corporation, +1-408-777-1417; or investors,
Stephanie C. Diaz, +1-415-885-2298, or sdiaz@vidaLLC.com, or media, Tim Brons,
+1-646-319-8981, or tbrons@vidaLLC.com, both of Vida Communication/
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, +1-888-776-6555 or +1-212-782-2840/
/Web site: http://www.www.durect.com/

Scroll to Top