DURECT Initiates Pivotal Phase III Program for the CHRONOGESIC(TM) (Sufentanil) Pain Therapy System

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CUPERTINO, Calif., Jul 9, 2002 /PRNewswire-FirstCall via COMTEX/ — DURECT
Corporation (Nasdaq: DRRX) announced today that it has begun dosing of patients
in the first clinical trial of its pivotal Phase III program for the
CHRONOGESIC(TM) (sufentanil) Pain Therapy System. The CHRONOGESIC product is a
pain relief system that continuously delivers sufentanil systemically for three
months and is intended for patients with opioid responsive malignant and
non-malignant chronic pain. Sufentanil is a pain relief medication that is
currently FDA-approved for use in hospitals as an analgesic. In previous
clinical studies, the CHRONOGESIC product was shown to have a favorable safety
and efficacy profile in over 70 patients.

“Our CHRONOGESIC therapy is the first systemic medication that may provide
patients with uninterrupted pain treatment for three months from a single
application. We believe the CHRONOGESIC therapy will be a significant
improvement over currently available long-term pain therapies on the market
today. We hope to provide physicians with a valuable medicine to potentially
treat the millions of underserved patients suffering from chronic pain,” stated
Jim Brown, President and Chief Executive Officer of DURECT. “We are very excited
to bring this new pain therapy to this advanced stage of development. The
initiation of our pivotal Phase III trials for this product represents an
important milestone for DURECT.”

Pivotal Phase III program

The objective of the Phase III program is to demonstrate that patients can be
safely transitioned from their existing pain relief medication to the
CHRONOGESIC product without compromising their pain relief.

DURECT’s pivotal Phase III program is anticipated to consist of four clinical
studies, which will enroll over 900 patients in total. The first trial is an
open-label safety study evaluating the CHRONOGESIC product in at least 100
patients for a period of 12 months. The pivotal Phase III program will also
include placebo-controlled safety and efficacy studies in the United States.
DURECT also plans to conduct a study to compare the CHRONOGESIC product to an
active control therapy to support European registration.

In the pivotal Phase III clinical trials, the primary endpoint is the success of
CHRONOGESIC in replacing other opioids while maintaining or improving pain
relief as indicated by an improvement in the pain visual analog score. Secondary
endpoints will include quality-of-life improvements and improved
gastrointestinal function such as constipation.

Previous Clinical Trials

In previous clinical trials for this product, DURECT developed a clinical
strategy to permit transition from a variety of opioid medications to the
CHRONOGESIC product and demonstrated better pain control and patient preference
for the CHRONOGESIC product. In September 2001, DURECT presented data from a
Phase II trial that enrolled 66 patients experiencing chronic pain due to failed
back surgery, cancer and other malignant and non-malignant causes. Patients were
transitioned from their pre-study opioid medication to a six-week period of

In a post-study survey, 60% of patients indicated a preference for CHRONOGESIC
over their pre-study medication and 35% of patients preferred their previous
medication (5% of patients indicated no preference). CHRONOGESIC also
demonstrated improvements in select side effects when compared to pre-study

The transition strategy developed in the Phase II trial was confirmed in an 18
patient pilot Phase III study, the results of which were presented in March
2002. In that trial patients were successfully converted from the Duragesic(R)
product, a 3-day transdermal fentanyl patch, to the CHRONOGESIC product without
observing clinically-relevant side effects or adverse events.

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. DURECT’s lead product in development, the CHRONOGESIC(TM)
(sufentanil) Pain Therapy System is a 3-month product for the treatment of
chronic pain. 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).

NOTE: CHRONOGESIC(TM) is a trademark of DURECT Corporation. SABER(TM),
MICRODUR(TM) and DURIN(TM) are trademarks of Southern BioSystems, Inc., a wholly
owned subsidiary of DURECT Corporation. Other trademarks referred to belong to
their respective owners.

The statements in this press release regarding DURECT’s products in development,
product development plans and clinical trials 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 research,
develop, manufacture and commercialize its products, obtain product and
manufacturing approvals from regulatory agencies, timely enroll patients and
clinical sites in connection with its clinical studies, effectively administer
its clinical trials, manage its growth and expenses, 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, 2001 filed with the
SEC on March 28, 2002, under the heading “Factors that may affect future
results,” and other periodic reports filed with the SEC. 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


Schond L. Greenway, Senior Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417 or


Copyright (C) 2002 PR Newswire. All rights reserved.

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