CUPERTINO, Calif., Jan. 26 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX), an emerging specialty pharmaceutical company, announced today
that it plans to expand its worldwide development program for its
post-operative pain relief depot, SABER(TM)-Bupivacaine, by initiating
additional Phase II studies for soft tissue and orthopedic surgical
procedures. In addition, clinical studies will be conducted in the U.S. under
the accepted U.S. Investigational New Drug (IND) application for
SABER-Bupivacaine.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
“The recent acceptance of our U.S. IND allows us to initiate clinical
studies with some of the leading surgeons in the U.S. in addition to other
countries around the world as we expand this clinical development program into
additional surgical procedures,” said James E. Brown, President and CEO of
DURECT. “DURECT intends to initiate the Phase III clinical program in the
second half of 2006.”
About SABER-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 local analgesia. DURECT recently announced positive
preliminary results for a Phase II dose escalation study in inguinal hernia
patients in Australia. DURECT believes that its post-operative pain relief
depot, if approved, has the potential to improve pain control, reduce opioid
consumption and their associated side effects and hospital stays for patients
that undergo surgery.
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.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT’s products in
development, anticipated product benefits, 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 successfully enroll 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 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
-0- 01/26/2006
/CONTACT: Schond L. Greenway, Vice President, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417/
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com/
/Web site: http://www.www.durect.com/
(DRRX)
CO: DURECT Corporation
ST: California
IN: BIO HEA MTC
SU: PDT
GM-DC
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4419 01/26/2006 06:30 EST http://www.prnewswire.com