Navigation Links
DURECT Announces Positive ELADUR(TM) Phase IIa Study Results
Date:12/18/2007

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.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
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
5. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
6. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
7. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
8. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
9. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
10. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
11. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... , Net Sales of $1.90 billion represent an increase ... period, and an increase of 1.2% on an adjusted pro ... first quarter were $0.52 reported, a decrease of 47.5% from ... 29.9% over the prior year period , The Company ... Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) ...
(Date:4/28/2016)... April 28, 2016  ValGenesis, Inc., the ... Solutions (VLMS) today announced that a prominent ... sufferers of chronic kidney failure has selected ... their corporate validation process. The global medical ... solution to manage their validation processes electronically. ...
(Date:4/27/2016)... , Schweiz, April 27, 2016 /PRNewswire/ ... des Sachs CEO Forums in Zürich gab ... ihres führenden Wirkstoffkandidaten STR001 zur Erhaltung des ... eingesetzt wurde, bekannt. Für die umfassende Phase-II-Doppelblindstudie ... und Frankreich angeworben. STR001 wird während der ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... 29, 2016 , ... Melanoma is the deadliest type of skin cancer. Although only about 1 ... skin cancer deaths. More than 10,000 people are expected to die of melanoma this year. ... is the one of the most commonly diagnosed cancers in young women. A recent breakthrough ...
(Date:4/29/2016)... ... April 29, 2016 , ... Reltok Nasal Products proudly announces that Boston ... and neck/ear, nose and throat specialty, has added the KOTLER NASAL AIRWAY™ to its ... is a newly patented safety device secured by nasal surgeons onto the floor ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... Dairy Products, Inc. in an upcoming episode, airing third quarter 2016 via Discovery ... churning cream into butter, Grassland Dairy Products, located in Greenwood, Wisconsin applies product ...
(Date:4/29/2016)... ... April 29, 2016 , ... The infertility specialists at HRC Fertility/Orange County ... Dr. Daniel A. Potter -- are proud of the recent release of their 2014 ... April, SART published the latest verified data for 375 U.S. member clinics. ...
(Date:4/29/2016)... ... 29, 2016 , ... International Dehydrated Foods, Inc. (IDF™) will attend and sponsor ... the Doubletree by Hilton Hotel in Oak Brook, Illinois. The two-day event is the ... protein ingredients. , At the seminar, IDF™ will offer samples of its Savory ...
Breaking Medicine News(10 mins):