DURECT Initiates Human Clinical Testing for Its Post-operative Pain Relief Depot Using the SABER(TM) Delivery System

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CUPERTINO, Calif., June 10 /PRNewswire-FirstCall/ —
DURECT Corporation (Nasdaq: DRRX) announced today that the Company has
commenced clinical testing of its post-operative pain relief depot product.
DURECT’s post-operative pain relief depot product, a sustained release
injectible using the SABER(TM) delivery system and a local anesthetic, is
designed to be administered locally around a surgical site after surgery for
post-operative pain relief. This pain relief product is intended to provide
local analgesia for up to three days, which coincides with the greatest need
for post surgical pain control in most patients. Bupivacaine, the active agent
for the product, is currently FDA-approved for use in hospitals as a local
anesthetic typically administered to patients in the post-surgical setting.
One dose of DURECT’s post-operative pain relief product is intended to provide
up to 72 hours of regional pain relief, compared to conventional practices,
which include both opioid and non-opioid medications. Currently, there are
more than 20 million surgical procedures performed annually in the US for
which this product could be potentially utilized.

“Our goal is to deliver an appropriate local anesthetic to the surgical
wound area, where adequate pain control can be achieved with minimal exposure
to the remainder of the body. In our market research, physicians indicated
that this product concept would represent an innovation over currently
available post-operative pain relief therapies,” stated James E. Brown,
President and Chief Executive Officer of DURECT. “This product could
potentially reduce hospital stays, the amount of traditional post-surgical
pain medications needed by patients, as well as with their associated side
effects resulting from the use of concomitant opioid medications. The start of
human clinical trials for this product is an important milestone for DURECT
and our SABER development programs.”

Post-operative Pain Study

The initial human clinical tests have been initiated in normal, healthy
volunteers in Europe. The objectives of the clinical study are to determine
the safety and tolerability of SABER and SABER-bupivacaine and to determine
the sensory effects of SABER-bupivacaine administered subcutaneously. The
product will be developed using DURECT’s patented SABER drug delivery system.
The SABER delivery system is a patented, biodegradable controlled-release
technology that can be formulated for parenteral, oral, dermal or other route
of administration of active agents for human pharmaceutical and veterinary

Special Note About Forward-Looking Statements

The statements in this press release regarding DURECT’s products in
development, clinical trials 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 of its products,
successfully complete clinical trials, manufacture and commercialize its
products, obtain product and manufacturing approvals from regulatory agencies,
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.”

NOTE: SABER(TM) is a trademark of DURECT Corporation. DURECT’s
post-operative pain product is under development and has not been submitted or
approved for commercialization by the US Food and Drug Administration or other
health authorities.


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

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