CUPERTINO, Calif., July 11, 2005 /PRNewswire-FirstCall via COMTEX/ — DURECT Corporation
(Nasdaq: DRRX) announced today the start of dosing in the third and final
cohort of the Phase II dose escalation study in hernia patients in Australia
for DURECT’s post-operative pain relief depot, SABER(TM)-Bupivacaine. The
Company anticipates that approximately 60 patients will be enrolled in cohort
3. SABER-Bupivacaine is based on DURECT’s patented SABER delivery technology
and is intended to be administered around the surgical site after surgery to
provide 3 days or more of regional pain relief.
“The findings of the second cohort indicate the potential for a
fundamental breakthrough in post-surgical pain control. In cohort 2, five of
the ten patients receiving SABER-Bupivacaine did not take any additional pain
medicine in the four days following open hernia surgery,” stated James E.
Brown, DVM, President and CEO of DURECT.
Phase II Study
The Phase II study is a dose escalation trial designed for dose
optimization of the product candidate. It includes three cohorts for the
treatment of pain in patients following repair of inguinal hernia. Six
patients were enrolled in cohort 1, and fifteen patients were enrolled in
cohort 2. The following will be evaluated in the study: safety,
pharmacokinetics, time to first supplemental analgesic, total supplemental
analgesic usage, pain intensity and pain relief.
Cohort 2 Preliminary Results
In June 2005, DURECT announced positive preliminary results from cohort 2
of the on-going Phase II study, reporting that patients who received SABER-
Bupivacaine did not use supplementary pain medication until an average of
approximately 45 to 60 hours following surgery compared to an average of
approximately 2 to 3 hours for the patients in the control group receiving
commercial bupivacaine (the current standard of care). These control patients
also took on average 4 times more doses of supplementary pain medication as
patients who received SABER-Bupivacaine. Five of the ten patients receiving
SABER(TM)-Bupivacaine took no supplemental analgesics over the four-day period
following treatment. Patients treated with SABER-Bupivacaine also reported
better overall mean pain relief and lower pain intensity scores over the four
days following treatment compared with patients treated with commercial
bupivacaine.
About DURECT Corporation
DURECT Corporation is an emerging specialty 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), the TRANSDUR(TM) transdermal technology and the
MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system).
DURECT also collaborates 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
four are in collaboration with pharmaceutical partners. Additional information
about DURECT is available at www.www.durect.com.
NOTE: SABER(TM), ORADUR(TM), DURIN(TM), TRANSDUR(TM) and MICRODUR(TM) are
trademarks of DURECT Corporation. Other referenced trademarks belong to their
respective owners.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT’s products in
development, anticipated product benefits and product development and clinical
trial 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 the product candidate, obtain product and
manufacturing approvals from regulatory agencies and manufacture and
commercialize the product candidate, as well as marketplace acceptance of the
product candidate. Further information regarding these and other risks is
included in DURECT’s Quarterly Report on Form 10-Q for the quarter ended March
31, 2005 filed with the SEC on May 6, 2005 under the heading “Factors that may
affect future results.”
SOURCE DURECT Corporation
Schond L. Greenway, Executive Director, Investor Relations and Strategic Planning of
DURECT Corporation, 408-777-1417
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