DURECT Completes Dosing of the Phase I Pharmacokinetic Study for Its Sufentanil Patch Product and of the First Cohort of the Phase II Study for Its Post-Operative Pain Relief Depot

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CUPERTINO, Calif., Feb. 10 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX), an emerging specialty pharmaceuticals systems company, today
announced the completion of dosing of the Phase I pharmacokinetic study for
DURECT’s TRANSDUR(TM)-based sufentanil patch. The Company also announced the
completion of dosing of the first cohort of the on-going Phase II clinical
study for DURECT’s SABER(TM)-based post-operative pain relief depot product
and is actively enrolling patients in the second cohort.

“Today, we are pleased to announce the completion of dosing of the Phase I
pharmacokinetic study for our TRANSDUR sufentanil patch. Our announced goal
for this program was to complete this study in the first half of 2005,” said
James E. Brown, DVM, DURECT’s President and Chief Executive Officer. “In
addition, the completion of dosing of the first cohort for our on-going Phase
II trial for our SABER-Bupivacaine product candidate is an important milestone
and advances this product to the next step in the clinical program. We believe
that these products, once approved, will provide a significant improvement
over currently available pain management therapies on the market today.”

DURECT’s TRANSDUR-based 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 opioid patches.
Further, we anticipate that the small size of our sufentanil patch
(potentially as small as 1/5th the size of currently marketed 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 $2.1 billion in 2004.

DURECT’s SABER-based post-operative pain relief depot product candidate is
intended to be administered around a surgical site after surgery to provide up
to 72 hours of regional pain relief and is based on our patented SABER
delivery system. We believe this product could potentially reduce hospital
stays and the amount of traditional post-surgical pain medications needed by
patients, as well as the side effects that result from the use of concomitant
opioid medications. We believe that there are currently more than 25 million
surgical procedures performed annually in the US for which this product could
be potentially used.

About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceuticals systems
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
DURIN(TM) Biodegradable Implant (drug-loaded implant system), the TRANSDUR(TM)
transdermal technology 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.

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

The statements in this press release regarding DURECT’s products in
development and product development plans 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 its
products, manufacture and commercialize its products, obtain product and
manufacturing approvals from regulatory agencies, manage its growth and
expenses, manage relationships with third parties, finance its activities and
operations, as well as marketplace acceptance of these products. Further
information regarding these and other risks is included in DURECT’s Quarterly
Report on Form 10Q for the quarter ended September 30, 2004 filed with the SEC
on November 5, 2004 under the heading “Factors that may affect future


investors, Schond L. Greenway Executive Director, IR and
Strategic Planning, 408-777-1417, or
press, Melissa M. Ta, Associate
Director, Corporate Communications, 408-777-1417,
both of DURECT
Corporation; or
investors, Stephanie C. Diaz, 415-885-2298, or
sdiaz@vidaLLC.com, or press, Tim Brons, 646-319-8981, or
both of Vida Communication, for DURECT Corporation/

/Web site: http://www.www.durect.com/
02/10/2005 07:30 EST http://www.prnewswire.com

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