DURECT Corporation Completes Validation of Terminal Sterilization Manufacturing Process for its CHRONOGESIC (sufentanil) Pain Therapy Product

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CUPERTINO, Calif., Sep 2, 2003 /PRNewswire-FirstCall via COMTEX/ — DURECT Corporation
(Nasdaq: DRRX) today announced that it has completed validation of the
terminal sterilization manufacturing process for its CHRONOGESIC (sufentanil)
Pain Therapy product.

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

“Our stated objectives this year were to implement some necessary design
and manufacturing enhancements to our CHRONOGESIC product and subsequently
restart our clinical program in the second half of 2003. In July, we announced
that we have completed the system optimization of our CHRONOGESIC product and
today, we are pleased to report that we have implemented both our design
enhancements and new terminal sterilization manufacturing process,” stated
James E. Brown, DVM, President and CEO of DURECT. “During the remainder of
this year, we intend to manufacture product to support clinical trials for our
CHRONOGESIC product and move this product back into the clinic.”

Terminal sterilization is the process of sterilizing the final packaged
product. In contrast, an aseptic packaging process requires individual product
components to be sterilized separately and the final package assembled in a
sterile environment. Terminal sterilization of a product provides greater
assurance of sterility than an aseptic process. In general, the ability to use
a terminal sterilization method can reduce various manufacturing costs for our
CHRONOGESIC product when compared to an aseptic manufacturing process.

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. In addition to its rights to the
CHRONOGESIC(R) product, 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).

trademarks of DURECT Corporation.

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 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, 2002 filed with the
SEC on March 14, 2003, DURECT’s Quarterly Report on Form 10Q and other
periodic reports filed with the SEC under the heading “Factors that may affect
future results.”

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.


Schond L. Greenway
Senior Director
Investor Relations and
Strategic Planning of DURECT Corporation
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