CUPERTINO, Calif., Dec 26, 2005 /PRNewswire via COMTEX News Network/ — CUPERTINO, Calif., Dec. 26 /PRNewswire-FirstCall/–DURECT Corporation
(Nasdaq: DRRX), an emerging specialty pharmaceuticals company, announced today
positive preliminary results from a multiple dose clinical study in chronic
pain patients for DURECT’s TRANSDUR(TM)-based sufentanil patch.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
“The preliminary results of this Phase II clinical study for the
TRANSDUR-Sufentanil patch indicate that the product performed as designed. The
top-line preliminary results of this study showed that patients can be
converted from the Duragesic(R) product to the TRANSDUR-Sufentanil product
safely without observing clinically relevant severe adverse events. Dosing on
TRANSDUR-Sufentanil was repeated for up to 4 consecutive weeks,” said James E.
Brown, DURECT’s President and CEO.
Clinical Study Design (Phase II)
The clinical study was an open-label study that was designed to evaluate
the transition of patients from Duragesic (commercial fentanyl patch) to the
TRANSDUR-Sufentanil patch. The clinical study also evaluated the
pharmacokinetics and safety of repetitive applications of the sufentanil patch
in chronic pain patients for a period of up to four weeks. The clinical trial
was conducted at 2 clinical sites (one in the United States and the other in
Europe) and enrolled 13 adult patients in the primary study with malignant or
non-malignant chronic pain.
Preliminary data indicate that all primary endpoints for the study were
achieved, which include:
— Pharmacokinetic — Evaluation of plasma level data indicate that
TRANSDUR-Sufentanil performed as designed by achieving its target
delivery profile of providing a rapid onset of drug and a delivery
duration of over 7 days. Targeted plasma levels over the consecutive
4-week period (repetitive applications of TRANSDUR-Sufentanil) were
achieved as intended.
— Safety — The product was tolerated well with no apparent safety issues
over the 4-week treatment period.
Preliminary Efficacy Observations:
— As this was an open label study, conclusions on efficacy cannot be
drawn; on average, pain levels remained stable after the transition to
TRANSDUR-Sufentanil.
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.
On March 14, 2005, DURECT granted Endo Pharmaceuticals Inc. the exclusive
license to develop and commercialize the TRANSDUR-Sufentanil patch in the U.S.
and Canada. This study was initiated prior to DURECT licensing this product to
Endo.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT’s and its
collaborative partners’ products in development, anticipated product benefits,
and clinical trial results and 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 (and that of its
third-party collaborators’, where applicable) abilities 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.”
NOTE: TRANSDUR(TM) is a trademark of DURECT Corporation. Other referenced
trademarks belong to their respective owners.
SOURCE DURECT Corporation
Schond L. Greenway, Executive Director, Investor Relations and Strategic Planning of
DURECT Corporation, +1-408-777-1417
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