CUPERTINO, Calif., Dec. 18 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today positive results from a Phase IIa clinical
trial for ELADUR(TM), DURECT’s proprietary investigational transdermal pain
patch. In this study of patients suffering from post-herpetic neuralgia,
ELADUR showed improved pain control versus placebo during the 3-day continuous
treatment period. In addition, ELADUR appeared well tolerated overall, and
patients treated with ELADUR and placebo exhibited similar safety profiles.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)
“To our knowledge, this is the first topical local anesthetic formulation
that supports a full 3 days of pain control from a single application,” stated
James E. Brown, DVM, President and CEO of DURECT. “In this study, ELADUR
showed comparable safety to placebo patches as well as good wearability
characteristics as patients went about their normal daily activities such as
exercising and showering while wearing the patches.”
This Phase IIa study was a randomized, multi-center, double-blind,
placebo-controlled, two-way cross-over study of 60 patients suffering from
post-herpetic neuralgia (post-shingles pain or PHN). The objectives of the
study were to assess the safety as well as the magnitude, duration and
characteristics of analgesic activity of ELADUR. DURECT anticipates that
detailed results will be submitted for presentation at the American Pain
Society Annual Meeting in May 2008.
About ELADUR
ELADUR is an investigational transdermal drug patch intended to provide up
to 3 days of local pain relief from a single application, as compared to a
wearing time limited to 12 hours with currently available anesthetic patches
(e.g., Lidoderm(R), an FDA-approved lidocaine patch for post-herpetic
neuralgia pain management). Bupivacaine, the active agent in ELADUR, is a
potent, FDA-approved long-acting local anesthetic used in regional anesthesia
including infiltration, nerve block, epidural and intrathecal anesthesia.
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 focused on treating chronic and episodic
diseases and conditions. The Company currently has multiple late-stage
pharmaceutical products in development initially focused on significant unmet
medical needs in pain management, with a number of research programs underway
in a variety of other therapeutic areas. For more information, please visit
http://www.www.durect.com.
NOTE: ELADUR(TM) is a trademark of DURECT Corporation. Other referenced
trademarks belong to their respective owners. ELADUR is a drug candidate
under development and has not been submitted or approved for commercialization
by the US Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding ELADUR, its anticipated
attributes and commercial potential, and future presentation of results at the
American Pain Society Meeting 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 design, enroll, conduct
and complete clinical trials, complete the design, development, and
manufacturing process development of ELADUR, obtain product and manufacturing
approvals from regulatory agencies and manufacture and commercialize ELADUR,
as well as marketplace acceptance of the product candidate, and the risk that
submissions to present clinical data at scientific meetings may not be
accepted by the sponsoring committee meeting. Further information regarding
these and other risks is included in DURECT’s Form 10-Q dated November 8, 2007
under the heading “Risk Factors.”
SOURCE DURECT Corporation
12/18/2007
CONTACT: Matt Hogan, Chief Financial Officer of DURECT Corporation,
+1-408-777-4936; or Jeremiah Hall, Senior Vice President of Feinstein Kean
Healthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com, for DURECT
Corporation
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