CUPERTINO, Calif., Oct 18, 2005 /PRNewswire-FirstCall via COMTEX News Network/ — DURECT Corporation
(Nasdaq: DRRX) announced today positive preliminary results from the Phase II
dose escalation study (Cohorts 1-3) in hernia patients in Australia for
DURECT’s post-operative pain relief depot, SABER(TM)-Bupivacaine.
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. These results were presented
to a group of surgeons attending the American College of Surgeons conference
in San Francisco, CA.
(Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
“We observed clear dose proportional pharmacokinetics in this study whilst
giving a continuous and stable delivery of bupivacaine over a period of four
days, with safety was demonstrated across all observed doses. Additionally,
this study provides promising preliminary data for SABER-Bupivacaine in those
areas considered clinically significant for post-surgical pain management,
namely reduced pain intensity, improved pain relief and a reduction in use of
supplemental opioid medication, providing encouraging results for the
possibility to reduce opioid-related side effects for post-surgical patients,”
stated Guy Patrick, MD, PhD, Premier Research Group plc., the physician who
oversaw the conduct of the Phase II study for DURECT.
“The preliminary findings from our Phase II study are very significant for
the SABER-Bupivacaine development program and DURECT in that they are
supportive of our established clinical objectives for this product candidate,”
stated James E. Brown, DVM, President and CEO of DURECT. “The data we have
seen to date support our continued efforts to move this program into
late-stage clinical development and indicate that SABER-Bupivacaine, if
approved, has the potential to be a significant improvement over the current
post-operative pain therapies on the market.”
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 and sixty patients in cohort 3.
Preliminary data indicate that all primary endpoints for the study were
achieved, which include:
— Pharmacokinetic — Evaluation of plasma bupivacaine concentrations
showed that SABER-Bupivacaine achieved its target delivery profile of
providing a delivery duration of over 72 hours with no burst upon
injection.
— Safety — No significant clinical adverse events or local or systemic
toxicity were observed, and the injections were well tolerated by the
patients.
— Established dose range for the product.
Other Preliminary Observations (Cohort 2 and Cohort 3, N=75)
— Using standardized pain evaluation methodology that has been recognized
by regulatory authorities to measure pain relief, patients treated with
SABER-Bupivacaine reported a trend for better overall mean pain relief
over the four days following treatment compared with patients treated
with commercial bupivacaine (Control).
— The SABER-Bupivacaine group had less pain intensity and required less
supplemental opioid analgesics over the four days following treatment
as compared to the Control group.
— The total numbers of doses of supplemental medication (opiate and
non-opiate) were the same in both treatment groups; however, the
SABER-Bupivacaine group utilized fifty percent (50%) less supplemental
opioid medication for post-operative pain over the four days following
treatment compared with the Control group.
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, 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 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 September 30, 2005 filed with the SEC on October 13,
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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