CUPERTINO, Calif., Sept. 6, 2011 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) announced today the dosing of the last patient in
the U.S. pivotal Phase III clinical study for POSIDUR® known as
BESST (Bupivacaine Effectiveness and Safety in SABER trial).
POSIDUR is a post-operative pain relief depot that utilizes
DURECT's patented SABER™ technology to deliver bupivacaine to
provide up to three days of pain relief after surgery. DURECT
expects to report top-line data from the BESST trial in the fourth
quarter of 2011 and, if the data are positive, to submit the New
Drug Application in the first half of 2012.
(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)
"We believe that POSIDUR has the potential to play a major role
in treating post-surgical pain, reducing the need for systemic
narcotics and associated side effects, as well as costs associated
with extended hospital stays," stated James
E. Brown, President and CEO.
"We are encouraged by this important development milestone for
POSIDUR, an innovative product candidate which may represent a
significant step-forward in the management of acute pain for
patients following surgical procedures. Hospira is committed to
bringing POSIDUR to market rapidly following FDA review and
approval," added Andrew Robbins,
Vice President, corporate development at Hospira, Inc. POSIDUR is
licensed to Hospira (NYSE: HSP) for commercialization in the U.S.
and Canada.
About the Design of BESST
BESST is an international, multi-center, randomized,
double-blind, controlled trial evaluating the safety, efficacy,
effectiveness, and pharmacokinetics of POSIDUR in 305 patients
undergoing a variety of general abdominal surgical procedures.
Eligible patients were randomly assigned to one of three
cohorts:
Cohort 1: An active comparator cohort in which 48 patients were
randomized to receive either POSIDUR 5.0 mL or commercially
available Bupivacaine HCl solution after laparotomy.
Cohort 2: An active comparator cohort in which 50 patients were
randomized to receive either POSIDUR 5.0 mL or commercially
available Bupivacaine HCl solution after laparoscopic
cholecystectomy.
Cohort 3: A double blind, placebo controlled cohort in which 207
patients were randomized to receive either POSIDUR 5.0 mL or
SABER-Placebo after laparoscopically-assisted colectomy.
Efficacy evaluation in the BESST trial will encompass a number
of parameters. The two co-primary efficacy endpoints for
Cohort 3 are mean pain intensity on movement (normalized) Area
Under the Curve (AUC) during the period 0-72 hours post-dose and
mean total morphine equivalent opioid dose for supplemental
analgesia during the period 0-72 hours post-dose. The purpose
of Cohorts 1 and 2 is to give additional experience with the use of
POSIDUR in a broader group of surgeries and patients; these smaller
cohorts were not intended to provide statistical significance with
respect to efficacy. In April
2010, DURECT had a FDA interaction which increased our
confidence that the BESST design and overall NDA strategy, subject
to data review from the entire POSIDUR development program,
addresses the FDA's comments provided during past interactions
regarding safety and evaluation of a diverse patient population
that is likely to be exposed to the marketed product.
About POSIDUR
POSIDUR is a post-operative pain relief depot that utilizes
DURECT's patented SABER™ technology to deliver bupivacaine to
provide up to three days of pain relief after surgery. POSIDUR is
licensed to Hospira for commercialization in the U.S. and
Canada, and to Nycomed for
commercialization in Europe and
other defined countries. DURECT has retained commercialization
rights in Japan and all other
countries not subject to the Nycomed and Hospira licenses.
About DURECT Corporation
DURECT is a specialty pharmaceutical company developing
innovative drugs for pain and other chronic diseases, with
late-stage development programs including REMOXY®, POSIDUR™,
ELADUR®, and TRANSDUR®-Sufentanil. DURECT's proprietary oral,
transdermal and injectable depot delivery technologies enable new
indications and superior clinical/commercial attributes such as
abuse deterrence, improved convenience, compliance, efficacy and
safety for small molecule and biologic drugs. For more
information, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding the anticipated
reporting of top-line data from BESST, submission of a New Drug
Application for POSIDUR, bringing of POSIDUR to market, and the
potential benefits and uses of POSIDUR 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, the risk of adverse decisions by regulatory agencies,
including product non-approval, delays and additional costs due to
requirements imposed by regulatory agencies, potential adverse
effects arising from the testing or use of POSIDUR, the potential
failure of BESST and our other clinical trials to meet their
intended endpoints, the potential that the data that we have
generated may not be deemed sufficient by FDA or other regulatory
agencies to support regulatory approval of POSIDUR, our potential
failure to maintain our collaborative agreements with third parties
or consummate new collaborations and DURECT's (and that of its
third party collaborators where applicable) difficulty or failure
to obtain approvals from regulatory agencies with respect to its
development activities and products, or ability to design, enroll,
conduct and complete clinical trials, complete the design,
development, and manufacturing process development of the
referenced product candidates, manufacture and commercialize the
referenced product candidates, obtain marketplace acceptance of the
referenced product candidates, avoid infringing patents held by
other parties and secure and defend patents of our own, and manage
and obtain capital to fund its growth, operations and expenses.
Further information regarding these and other risks is included in
DURECT's Form 10-Q on August 5, 2011
under the heading "Risk Factors."
NOTE: POSIDUR™, SABER™, ORADUR®, TRANSDUR®, and ELADUR™ are
trademarks of DURECT Corporation. Other referenced trademarks
belong to their respective owners. REMOXY, POSIDUR, ELADUR
and TRANSDUR-Sufentanil are drug candidates under development and
have not been approved for commercialization by the U.S. Food and
Drug Administration or other health authorities.
SOURCE DURECT Corporation