DURECT Corporation Completes the Clinical Portion of Phase II Clinical Trial for DUROS Sufentanil

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CUPERTINO, Calif., May 11 /PRNewswire/ —
DURECT Corporation (Nasdaq: DRRX) announced today that the company has
completed the clinical portion of its Phase II clinical trial for the
company’s lead product, DUROS sufentanil. The last patient visit was completed
and data analysis and report writing are underway. Over 50 patients at
9 clinical centers completed the clinical portion of the study more than
3 months ahead of schedule. DUROS sufentanil is designed to deliver sufentanil
on a continuous basis for 3 months for the treatment of chronic pain.
Sufentanil is an FDA approved opioid that is currently used in hospitals as an
anesthetic. Chronic pain is a significant problem associated with chronic
diseases, including cancer and various neurological and skeletal disorders.
DUROS sufentanil is intended for patients whose chronic pain is stable, opioid
responsive and results from a variety of malignant and non-malignant causes.
Annual sales of opioids for the treatment of chronic pain are in excess of
$1 billion.

This Phase II trial was designed to determine the dose conversion from
other approved opioid medications to DUROS sufentanil. DURECT utilized an
advisory panel of leading clinical physicians and experts in the field of
chronic pain to develop the protocol for the Phase II trial. The trial
evaluated the safety and efficacy of continuous dose of sufentanil via a
subcutaneously implanted DUROS sufentanil system in stable opioid responsive
chronic pain patients. The information on relative potency and conversion
charts collected in this study will be used in Phase III trials designed to
demonstrate the safety and efficacy of the DUROS sufentanil product.

“We are very pleased at the progress that we have made with our Phase II
trial for DUROS sufentanil. The accelerated pace exceeds our expectations,”
said James E. Brown, President and CEO of DURECT. “We believe that this
reflects the potential benefits of this product to both patients and
physicians. We believe DUROS sufentanil has the potential to be a more
convenient, patient-friendly product that may provide an alternative to
current therapies for the long term treatment of stable and opioid responsive
chronic pain.”

“We believe that the rapid patient enrollment and completion of this Phase
II trial is due to the tremendous enthusiasm of our investigators for this
product, which we expect to carry forward to our Phase III trials,” said
Dennis Fisher, MD, Vice President of Medical Affairs and Medical Director of

DURECT Corporation is pioneering the development and commercialization of
pharmaceutical systems to deliver the right drug to the right site in the
right amount at the right time. DURECT’s pharmaceutical systems combine
technology innovations from the medical device and drug delivery industries
with proprietary pharmaceutical and biotechnology drug formulations. These
capabilities can enable new drug therapies or optimize existing therapies
based on a broad range of compounds, including small molecule pharmaceuticals
as well as biotechnology molecules such as proteins, peptides and genes.

DURECT’s second product in development, DUROS hydromorphone, continuously
delivers hydromorphone to the spine. DURECT also sells FDA cleared catheters
for the delivery of fluids to the inner ear and manufactures and sells and
distributes the ALZET osmotic pump product for use in laboratory research.

Southern BioSystems, Inc., a wholly owned subsidiary of DURECT
Corporation, researches, develops and manufactures controlled-release drug
delivery products to help clients commercialize human and veterinary
pharmaceuticals. Southern BioSystems has three drug-delivery platforms: the
proprietary SABER(TM) delivery system, microspheres and drug-loaded implants.
SABER(TM) is a biodegradable highly viscous liquid that can be formulated for
oral, parenteral dermal or other routes of administration. Southern BioSystems
has the capabilities to formulate microspheres for oral, parenteral dermal or
other routes of administration. Southern BioSystems also develops drug-loaded
implants and, through its subsidiary Birmingham Polymers, also manufactures
biodegradable polymers.

Founded in 1998, DURECT is headquartered in Cupertino, CA. The company’s
World Wide Web site can be accessed at http://www.www.durect.com. The company’s
World Wide Web site for ALZET osmotic pumps, IntraEAR and Southern BioSystems,
Inc. can be accessed at http://www.alzet.com, http://www.intraear.com and
http://www.southernbiosystems.com, respectively. To join DURECT’s email alert
service, please register by selecting “Email Alerts” on the main Investor
Relations web page at http://www.www.durect.com.

DUROS is a registered trademark of ALZA Corporation. SABER(TM) is a
trademark of Southern BioSystems, Inc., a subsidiary of DURECT Corporation.

The statements in this press release regarding DURECT’s products in
development, product development plans, or expected product benefits, are
forward-looking statements involving risks and uncertainties that could 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 develop, manufacture and commercialize its products,
complete successful clinical trials, obtain product approvals from regulatory
agencies, and build a manufacturing facility, as well as marketplace
acceptance of DURECT’s products. Further information regarding these and other
risks is included in the company’s S-1 registration statement, filed with the
SEC on September 22, 2000, 424(b) prospectus filed with the SEC on
September 28, 2000, Quarterly Report on Form 10Q for the quarter ended
September 30, 2000 filed with the SEC on November 14, 2000 and Annual Report
on Form 10K for the fiscal year ended December 31, 2000 filed with the SEC on
March 30, 2001.

For further information please contact:

DURECT Corporation

Schond L. Greenway

Director, Investor Relations

Phone: (408) 777-1417


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CONTACT: Schond L. Greenway, Director, Investor Relations of DURECT
Corporation, 408-777-1417, schond.greenway@durect.com/

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