Navigation Links
DURECT Announces Positive ELADUR(TM) Phase IIa Study Results

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.


"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.


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

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."

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:
(Date:10/2/2017)... Lilly and Company (NYSE: LLY ) will ... 2017 on Tuesday, October 24, 2017. Lilly will also ... investment community and media to further detail the company,s ... at 9 a.m. Eastern time. Investors, media and the ... conference call through a link that will be posted ...
(Date:9/28/2017)... CHICAGO , Sept. 28, 2017 Hill-Rom ... quarter 2017 earnings conference call and webcast on Friday, ... 8:00 a.m. (EDT) and ending at approximately 8:30 a.m. ... to discussing the company,s 2017 financial performance and guidance ... growth opportunities, initiatives to enhance operational performance, and long-range ...
(Date:9/25/2017)... , Sept. 25, 2017   Montrium , ... File solutions, today—from the IQPC Trial Master Files ... , NL)—announced that EastHORN Clinical Services has selected ... programs and TMF management. EastHORN, a leading European ... platform to increase transparency to enable greater collaboration ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 2017 , ... Lori R. Somekh, founder of the Law Office of ... elder law and special needs planning attorneys. “Membership in ElderCounsel helps our office remain ... to network with elder law attorneys nationwide,” said Somekh. , ElderCounsel ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids ... Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, ... run is geared towards children of all ages; it is a non-competitive, non-timed event, ...
(Date:10/13/2017)... ... ... “America On The Brink”: the Christian history of the United States and the loss ... author, William Nowers. Captain Nowers and his wife, Millie, have six children, ten ... the Navy. Following his career as a naval aviator and carrier pilot, he ...
(Date:10/12/2017)... ... ... IsoComforter, Inc. ( ), one of the Nation’s premier ... of the shoulder pad. The shoulder pad provides optimal support and full contact ... using cold therapy. By utilizing ice and water that is circulated from an insulated ...
(Date:10/12/2017)... Malvern, PA (PRWEB) , ... October 12, 2017 , ... ... is the recipient of a 2017 Folio Magazine Eddie Digital Award for ‘Best ... New York City on October 11, 2017. , The annual award competition recognizes editorial ...
Breaking Medicine News(10 mins):