DURECT Corporation Enrolls Patients in Phase II Clinical Trial for DUROS Sufentanil

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CUPERTINO, Calif., Dec. 11 /PRNewswire/ — DURECT Corporation
(Nasdaq: DRRX) today announced enrollment of the patients into a Phase II
clinical trial for the company’s lead product, DUROS sufentanil, for the
treatment of chronic pain. DUROS sufentanil uses the DUROS osmotic delivery
system to deliver sufentanil on a continuous basis for 3 months. Sufentanil is
an off-patent, highly potent opioid that is currently used in hospitals as an
anesthetic. Chronic pain, defined as pain lasting 6 months or longer, 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 and opioid responsive and results from a
variety of malignant and non-malignant causes. Annual sales of opioids for the
treatment of chronic pain are approximately $1 billion.

Traditionally, a Phase II clinical trial evaluates dose response concerns.
In the case of DUROS sufentanil, because the drug has a well-understood safety
and efficacy profile and the validity of the DUROS technology platform for
providing drug therapy has been demonstrated by the Food and Drug
Administration’s approval of ALZA’s Viadur product, the focus of this Phase II
trial is designed to determine the dose conversion of 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, which is expected to include
approximately 50 patients at 10-12 clinical centers, is projected to be
completed in the second half of 2001. The trial is designed to address
several issues relevant to the eventual commercial product. Patients with
opioid-responsive pain will be converted from their present opioids
(narcotics) to DUROS sufentanil with an equianalgesic dose identified in the
crossover segment of the study. The trial will evaluate the safety and
efficacy of continuous dose 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 to demonstrate the safety and efficacy of the
DUROS sufentanil product.

Commenting on the trial, James E. Brown, D.V.M., President and Chief
Executive Officer of DURECT, stated, “We are very pleased to reach this
milestone for our lead product. We believe that DUROS sufentanil may have
numerous advantages for the patient as well as the physician, including a
consistent dosing regimen and increased patient compliance. 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.”

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 initial portfolio of products combine the DUROS technology, a
proven and patented drug delivery platform licensed for specified fields of
use from ALZA Corporation, with drugs for which medical data on efficacy and
safety are available. Founded in 1998, the Company is headquartered in
Cupertino, CA. The Company’s World Wide Web site can be accessed at
http://www.www.durect.com. To join DURECT’s email alert service, please register
by selecting “Email Alerts” on the main Investor Relations web page at

DUROS is a registered trademark of ALZA Corporation.

The statements in this press release regarding DURECT’s products in
development, product development plans, clinical trials, and 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, build a manufacturing facility, marketplace acceptance of
DURECT’s products and DURECT’s ability to manage its growth and costs. 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, its 424(b)
prospectus filed with the SEC on September 28, 2000 and its Quarterly Report
on Form 10Q for the quarter ended September 30, 2000 filed with the SEC on
November 13, 2000.

For further information please contact:

DURECT Corporation

Schond L. Greenway

Director, Investor Relations

(408) 777-1417


Noonan/Russo Communications

Tom Baker

Media Relations

Phone: (415) 677-4455 Ext. 370


CONTACT: Schond L. Greenway Director, Investor Relations of DURECT
Corporation, 408-777-1417, Schond.Greenway@Durect.com; or Tom Baker Media
Relations at Noonan/Russo Communications, 415-677-4455 ext. 370,
T.Baker@NoonanRusso.com, for DURECT Corporation/

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