CUPERTINO, Calif., Oct. 25 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today the initiation of a Phase II clinical study for
its post-operative pain relief depot (SABER-bupivacaine), a sustained-release
formulation of a local anesthetic using the Company’s SABER(TM) drug delivery
system. SABER-bupivacaine is designed to be administered, via injection,
around an incision site following surgery for post-operative pain relief. One
dose of SABER-bupivacaine is intended to provide up to 72 hours of regional
pain relief.
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“On the strength of the results of our Phase I data that showed good
safety and tolerability as well as up to 3 days of drug release, we are very
excited to advance this program into Phase II development. We believe that our
post-operative pain relief depot, once approved, will reduce opioid
consumption and their associated side effects and hospital stays for numerous
patients that undergo surgery each day,” said James E. Brown, President and
CEO of DURECT.
DURECT worked with an advisory panel of leading clinical physicians and
experts in the field of post-surgical pain management to develop the protocol
for the Phase II trial. The Company anticipates that the trial will enroll
approximately 65 patients, with an option to enroll an additional 30 patients,
for a possible total enrollment of 95 patients in the trial. The Phase II
trial will be a dose escalation study, conducted in three parts. All parts of
the trial will be conducted in Australia as an open label study for the
treatment of pain in patients following repair of inguinal hernia. Patients
will be administered with SABER-bupivacaine at the completion of surgery, and
the trial will evaluate the safety and efficacy of the injection. The primary
end points for the trial will include a pharmacokinetic evaluation of plasma
bupivacaine levels, time to first supplemental analgesic, analysis of the sum
of pain intensity and analysis of total pain relief. The information on dose
response collected in this study will be used in future Phase III trials to
demonstrate the safety and efficacy of the SABER-bupivacaine product.
Physician-based market research conducted by the Company indicated that
this product may represent an innovation over currently available post-
operative pain relief therapies. The Company believes this product could
potentially reduce hospital stays and the amount of traditional post-surgical
pain medications needed by patients, as well as the side effects that result
from the use of concomitant opioid medications. The Company believes that
there are currently more than 25 million surgical procedures performed
annually in the US for which this product could be potentially used.
About DURECT Corporation
DURECT Corporation is a pharmaceutical company focused on the development
of pharmaceutical systems based on its proprietary drug delivery platform
technologies that treat chronic debilitating diseases and enable biotechnology
products. These platform technologies include the SABER(TM) Delivery System
(a patented and versatile depot injectable useful for protein and small
molecule delivery), the ORADUR(TM) sustained release oral gel-cap technology
(an oral sustained release technology with several potential abuse deterrent
properties), the DURIN(TM) Biodegradable Implant (drug-loaded implant system)
and the MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable
system). DURECT also partners with pharmaceutical companies to develop and
commercialize proprietary and enhanced pharmaceutical products based on its
technologies. DURECT has five disclosed on-going development programs of
which three are in collaboration with pharmaceutical partners. Additional
information about DURECT is available at www.www.durect.com.
NOTE:
SABER(TM), ORADUR(TM), DURIN(TM) and MICRODUR(TM) are trademarks of DURECT
Corporation.
The statements in this press release regarding DURECT’s products in
development, product development plans, clinical trials and potential product
benefits and markets 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 as well as marketplace acceptance of its 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, 2003 filed with the
SEC on March 11, 2004, DURECT’s Quarterly Report on Form 10-Q and other
periodic reports filed with the SEC under the heading “Factors that may affect
future results.”
The SABER-bupivacaine product referred to in this press release is under
development and has not been submitted or approved for commercialization by
the US Food and Drug Administration or other health authorities.
SOURCE DURECT Corporation
/CONTACT: Schond L. Greenway, Mxecutive Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417/
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