CUPERTINO, Calif., Nov. 6 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today that the Company has completed its first study
in humans with its post-operative pain relief depot product. DURECT’s
post-operative pain relief depot product, a sustained release injectable using
the SABER delivery system and a local anesthetic, is designed to be
administered locally around a surgical site after surgery for post-operative
pain relief. One dose of DURECT’s post-operative pain relief product is aimed
at providing up to 72 hours of regional pain relief, to reduce hospital stays
and opioid consumption.
(Photo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
“We are very pleased with the good biocompatibility we have seen with the
SABER depot in these subjects,” stated Dr. James E. Brown, President and CEO
of DURECT. “The plasma concentration of drug measured in these subjects
allowed us to estimate the extent and rate of absorption in these subjects.
This study increased our confidence in the capabilities of the SABER depot
technology, and is very positive for further development of a SABER
bupivacaine product.”
Post-operative Pain Depot Study
The initial human clinical tests were completed in 12 normal, healthy
volunteers in Europe. The objectives of the clinical study were to determine
the safety and tolerability of SABER and SABER-bupivacaine, as well as
evaluate the pharmacokinetics of our SABER product versus current treatment
methods, which included bupivacaine and ropivacaine. The subjects in this
study were injected with a SABER placebo compared with a SABER depot
containing a low dose of bupivacaine. The extent of absorption of the drug was
100% and the rate of absorption of drug from the depot was found to be
continuous for three days as designed. The release of our drug product over
3 days is a significant improvement over the current treatment methods, which
typically lasts for 4 to 6 hours.
Physicians that participated in the market research surveys for this
product indicated that this product concept would represent an innovation over
currently available post-operative pain relief therapies. 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. Currently,
there are more than 20 million surgical procedures performed annually in the
US for which this product could be potentially utilized.
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. In addition to its rights to the
CHRONOGESIC(R) product, 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(R), SABER(TM), MICRODUR(TM) and DURIN(TM) are
trademarks of DURECT Corporation.
The statements in this press release regarding DURECT’s products in
development 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 development of its
products, manufacture and commercialize its products, obtain product and
manufacturing approvals from regulatory agencies, manage its growth and
expenses, 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.”
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 authorities.
SOURCE DURECT Corporation
CONTACT:
Schond L. Greenway
Senior Director
Investor Relations and
Strategic Planning of DURECT Corporation
408-777-1417
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