CUPERTINO, Calif., June 20 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today positive preliminary results from the second
cohort of an on-going Phase II clinical study in hernia patients for DURECT’s
post-operative pain relief depot product candidate, 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
on June 18th at the International College of Surgeons (ICS) 39th North
American Federation Congress in Acapulco, Mexico.
“The preliminary findings from our Phase II study are very significant for
the SABER-Bupivacaine development program and DURECT in that they are
supportive thus far of all our established clinical objectives for this
product candidate of safety, a drug delivery duration of 3 days or more, and
in comparison to the current standard of care, improved pain relief and
reduction in the use of supplemental analgesic medication. Of note, five of
the ten patients receiving SABER-Bupivacaine in cohort 2 of our Phase II study
took no supplemental analgesics over the four-day period following treatment,”
stated James E. Brown, DVM, President and CEO of DURECT.
Phase II Study
This Phase II trial is a dose escalation study underway in Australia. The
trial is designed to include 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. Patients in cohort 2
received injections of either SABER-Bupivacaine or commercial bupivacaine (the
current standard of care) at the completion of surgery. Patients were allowed
to take supplemental analgesic medication to address their breakthrough pain.
The following were evaluated in the study: safety, pharmacokinetics, time to
first supplemental analgesic, total supplemental analgesic usage, pain
intensity and pain relief. The Company anticipates that approximately 60
patients will be enrolled in cohort 3 of the Phase II study.
Cohort 2 Preliminary Results
Safety and Pharmacokinetic Evaluation
No significant clinical adverse events or local or systemic toxicity were
observed, and the injections were well tolerated. 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.
Pain Management Assessment
Using standardized pain evaluation methodology that has been recognized by
regulatory authorities to measure pain relief, patients treated with SABER-
Bupivacaine reported better overall mean pain relief over the four days
following treatment compared with patients treated with commercial bupivacaine
(Control). Patients treated with SABER-Bupivacaine also reported lower pain
intensity scores than the Control group using a visual analog scale (VAS) over
the four days following treatment.
Use of Supplemental Analgesics
Patients treated with SABER-Bupivacaine took fewer doses of supplemental
analgesics during the four days following treatment compared with patients in
the Control group. In addition, the length of time prior to the first dose of
supplemental analgesics was greater for patients treated with SABER-
Bupivacaine than for patients in the Control Group.
The following tables below provide a summary of the preliminary results
from cohort 2:
Table 1 - Pain Management Assessment over 4 Days
Study Product Mean Mean VAS Summed Pain
(Bupivacaine injection Overall Pain Intensity Score (+/-SD)
dose in mg.) Relief over
4 Days At Rest Coughing
Group 1 SABER-Bupivacaine A Lot 313+/-423 781+/-521
+ Saline (638mg) - (n=5)
Group 2 SABER-Bupivacaine A Lot 636+/-514 1,585+/-1,240
+ Commercial Bupivacaine
(688mg) - (n=5)
Control Commercial Bupivacaine Some 2,770+/-1,644 4,387+/-1,033
(75mg) - (n=5)
Table 2 - Mean Time to Supplemental Analgesic (Hrs.) and
Mean Supplemental Analgesic Dosage taken over 4 Days
(No. of Doses)
Study Product Mean Time to Mean
(Bupivacaine Injection Dose in mg.) Supplemental Supplemental
Analgesic (Hrs.) Analgesic Doses
over 4 Days (No.)
Group 1 SABER-Bupivacaine 60.4 2.6
+ Saline (638mg) - (n=5)
Group 2 SABER-Bupivacaine 44.9 2.4
+ Commercial Bupivacaine
(688mg) - (n=5)
Control Commercial Bupivacaine 2.3 11.0
(75mg) - (n=5)
NOTE:
1) Five of the ten patients receiving SABER(TM)-Bupivacaine
(> or = 638 mg) took no supplemental analgesics over the four-day period
following treatment.
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
06/20/2005
CONTACT: Schond L. Greenway, Executive Director, Investor Relations and
Strategic Planning of DURECT Corporation, 408-777-1417
/Web site: http://www.www.durect.com /