CUPERTINO, Calif., April 27 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX), an emerging specialty pharmaceuticals company, provided an
update on its post-operative pain relief depot, SABER(TM)-Bupivacaine program.
DURECT announced results from its Phase II Australian clinical study in hernia
patients and the initiation of dosing in the first U.S. clinical trial, a
Phase II, placebo-controlled trial in hernia patients.
Commenting on the program, Dr. Felix Theeuwes, Chairman and Chief
Scientific Officer of DURECT, said, “We are pleased with how this dosage form
performs in the clinic, in particular its ease of use in the clinical setting
and the controlled local delivery of bupivacaine at the surgical site, where
SABER-Bupivacaine is applied. This performance is reflected in the good
pharmacokinetics and safety data obtained in this first Phase II study. Based
on the well known efficacy of immediate release bupivacaine, the clinical
experience generated from local infusions of bupivacaine via catheter around
surgical sites, and the good safety and pharmacokinetics data from this trial,
we feel confident that the remainder of our Phase II program will define the
optimum dosing of SABER-Bupivacaine for local post-surgical pain management.”
Phase II Australian Hernia Study
The Phase II trial was a dose escalation trial conducted in three cohorts,
where three doses, low (Cohort 1), intermediate (Cohort 2) and high
(Cohort 3), of SABER-Bupivacaine was evaluated following repair of inguinal
hernia. In Cohorts 1, 2 and 3, a total of 6, 15 and 60 patients were
enrolled, respectively. Cohorts 2 and 3 included control groups of 5 and 15
patients, respectively, who received commercial bupivacaine as a comparator.
Prior to dose escalation, safety and an acceptable pharmacokinetic profile
were established. The primary end points of the study were safety and
pharmacokinetics. The study also assessed a variety of other secondary
endpoints including, among others, pain intensity, pain relief and
supplemental analgesic medication usage. Although the study was not designed
as an efficacy study to provide statistical conclusions on such secondary
endpoints, results from these evaluations are intended to guide the design of
future Phase II and Phase III clinical studies.
Study Results The results to date from the study are as follows: All primary end-points of the study were achieved: -- Safety -- Good safety was observed across all Cohorts, with no clinically significant drug related adverse events observed with 61 patients exposed to SABER-Bupivacaine. SABER-Bupivacaine injections also appeared to be well tolerated by patients. -- Pharmacokinetics -- Evaluation of plasma bupivacaine concentrations showed that, across all Cohorts, SABER-Bupivacaine achieved: -- sustained plasma concentrations of bupivacaine as measured up to 72 hours -- no evidence of burst or spike in plasma concentrations of bupivacaine upon injection -- dose linear pharmacokinetics of bupivacaine
Secondary End-points (in Cohort 2 and Cohort 3 with comparator controls
-- In Cohort 2 (n=15), the patients who were administered SABER-Bupivacaine showed better pain relief, lower pain intensity and reduced supplemental analgesic usage compared with the patients using commercial bupivacaine as measured during the first 4 days after treatment. -- In Cohort 3 (n=60), no significant difference was observed in pain relief, pain intensity and supplemental analgesic usage between the patients who were administered SABER-Bupivacaine compared with the patients using commercial bupivacaine as measured during the first 4 days after treatment. Update on Phase II Program
Dosing has been initiated in the first clinical trial in the U.S., a Phase
II, placebo-controlled trial intended to enroll up to 90 patients following
hernia surgery. In addition, a Phase II trial in hernia patients is on-going
in the United Kingdom. During the remainder of this year, we intend to
initiate several Phase II trials in the U.S. and in other countries in a
variety of soft-tissue and orthopedic surgery models for the purpose of
selecting the optimal dose and the pain models to be used for our pivotal
trials. Pending the successful completion of these Phase II trials and
approval of regulatory authorities, we will continue into Phase III trials.
Our SABER-Bupivacaine depot under development is a sustained-release
formulation of bupivacaine, an off-patent local anesthetic, using our patented
SABER delivery system for the treatment of post-surgical pain.
SABER-Bupivacaine is intended to be administered by the surgeon around the
incision at the time of surgery. Placed in the tissues near or adjacent to the
surgical site, this formulation is designed to provide sustained regional
analgesia from a single dose. We believe that by delivering effective amounts
of a potent anesthetic to the location from which the pain originates,
adequate pain control can be achieved with minimal exposure to the remainder
of the body, and hence minimal side effects. SABER-Bupivacaine is intended to
provide local analgesia of 3 days or more, which we believe coincides with the
time period of greatest need for post-surgical pain control in most patients.
We retain the full commercialization rights to SABER-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. Additional information about DURECT is
available at www.www.durect.com.
NOTE: SABER(TM) is a trademark 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 clinical trial results and
future 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 successfully design, enroll,
conduct and complete clinical trials, 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 Annual Report on Form 10-K filed with the SEC on March
16, 2006 under the heading “Risk Factors.”
SOURCE DURECT Corporation -0- 04/27/2006 /CONTACT: Schond L. Greenway, Vice President, Investor Relations and Strategic Planning of DURECT Corporation, +1-408-777-1417/ /Photo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO AP Archive: http://photoarchive.ap.org PRN Photo Desk, email@example.com/ /Web site: http://www.www.durect.com/ (DRRX) CO: DURECT Corporation ST: California IN: MTC HEA SU: TRI JA-MW -- SFTH039 -- 7273 04/27/2006 06:30 EDT http://www.prnewswire.com