DURECT Corporation Announces Completion of Dosing in Cohort 3 of its Phase II Study for its Post-Operative Pain Relief Depot

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CUPERTINO, Calif., Sept. 19 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX – News), an emerging specialty pharmaceutical company, announced
today the completion of dosing in the third and final cohort of the Phase II
dose escalation study in hernia patients in Australia for DURECT’s
post-operative pain relief depot, SABER(TM)-Bupivacaine. The Company completed
enrollment of approximately 60 patients in cohort 3. SABER-Bupivacaine is
based on DURECT’s patented SABER delivery technology and is intended to be
administered around the surgical site after surgery to provide 3 days or more
of regional pain relief. The results of cohort 3 are currently being analyzed.

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

“The completion of dosing of the third and final cohort for this 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,” stated
James E. Brown, DVM, President and CEO of DURECT. “The clinical performance of
this product from the second cohort has confirmed our expectation that this
product has the potential to be a very significant improvement over the
current modalities of post-operative pain therapies on the market. We look
forward to announcing the data from this third cohort later this year.”

Phase II Study

The Phase II study is a dose escalation trial designed for dose
optimization of the product candidate. It includes three cohorts for the
treatment of pain in patients following repair of inguinal hernia. Six
patients were enrolled in cohort 1, and fifteen patients were enrolled in
cohort 2. The following attributes are being evaluated in the study: safety,
pharmacokinetics, time to first supplemental analgesic, total supplemental
analgesic usage, pain intensity and pain relief.

About DURECT Corporation

DURECT Corporation is an emerging specialty 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 DURIN(TM) Biodegradable Implant
(drug-loaded implant system), the TRANSDUR(TM) transdermal technology and the
MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system).
DURECT also collaborates 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
four 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.

DURECT Forward-Looking Statement

The statements in this press release regarding DURECT’s products in
development, anticipated product benefits and product development and clinical
trial 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 successfully complete clinical trials,
complete the design, development, and manufacturing process development of the
product candidate, obtain product and manufacturing approvals from regulatory
agencies and manufacture and commercialize the product candidate, as well as
marketplace acceptance of the product candidate. Further information regarding
these and other risks is included in DURECT’s Quarterly Report on Form 10-Q
for the quarter ended June 30, 2005 filed with the SEC on August 4, 2005 under
the heading “Factors that may affect future results.”



/CONTACT: Schond L. Greenway, Executive Director, Investor Relations and
Strategic Planning, of DURECT Corporation, +1-408-777-1417/

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