CUPERTINO, Calif., Feb. 16 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX), an emerging specialty pharmaceuticals systems company, today
announced the initiation of the Phase II program for DURECT’s
TRANSDUR(TM)-based sufentanil patch. Based on the results of our Phase I trial
for our TRANSDUR-Sufentanil patch that showed good safety, tolerability and
drug release for up to 7 days, we initiated the first clinical trial in our
Phase II program.
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“The initiation of the Phase II program for the TRANSDUR-Sufentanil patch
is an important milestone for us. We have been able to move this program
rapidly from Phase I in October 2004, in part due to our Phase II and dose
conversion data from our clinical studies with our CHRONOGESIC(R) product,”
said James E. Brown, DURECT’s President and CEO. “Our previous experience with
the systemic delivery of sufentanil in approximately 100 patients with
CHRONOGESIC is directly applicable to the development of our
TRANSDUR-Sufentanil patch.”
Phase II Program
The objectives of the Phase II program are to evaluate the
pharmacokinetics, efficacy, and safety of repetitive applications of our
sufentanil patch in chronic pain patients for a period of up to four weeks.
About TRANSDUR-Sufentanil
DURECT’s TRANSDUR-based transdermal sufentanil product is intended to
provide extended chronic pain relief for up to seven days, as compared to the
three days of relief provided with currently available opioid patches.
Further, we anticipate that the small size of our sufentanil patch
(potentially as small as 1/5th the size of currently marketed transdermal
fentanyl patches for a therapeutically equivalent dose) may offer improved
convenience for patients. Worldwide sales for DURAGESIC(R), a leading
transdermal fentanyl product, exceeded $2.1 billion in 2004.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceuticals systems
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 partners 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 three are in collaboration with pharmaceutical
partners. Additional information about DURECT is available at www.www.durect.com.
The statements in this press release regarding DURECT’s products in
development and 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 its
products, manufacture and commercialize its products, obtain product and
manufacturing approvals from regulatory agencies, manage its growth and
expenses, manage relationships with third parties, finance its activities and
operations, as well as marketplace acceptance of these products. Further
information regarding these and other risks is included in DURECT’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2004 filed with the
SEC on November 5, 2004 under the heading “Factors that may affect future
results.”
NOTE: CHRONOGESIC(R), SABER(TM), ORADUR(TM), DURIN(TM), TRANSDUR(TM) and
MICRODUR(TM) are trademarks of DURECT Corporation. Other referenced trademarks
belong to their respective owners.
SOURCE DURECT Corporation
02/16/2005
CONTACT: investors, Schond L. Greenway, Executive Director, IR and
Strategic Planning, 408-777-1417, or
media, Melissa M. Ta, Associate
Director, Corporate Communications, 408-777-1417,
both of DURECT
Corporation; or
investors, Stephanie C. Diaz, 415-885-2298, or
sdiaz@vidaLLC.com, or
media, Tim Brons, 646-319-8981, or
tbrons@vidaLLC.com,
both of Vida Communication, for DURECT Corporation/
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02/16/2005 07:30 EST http://www.prnewswire.com