Navigation Links
ELADUR(TM) Development Update: DURECT Receives Orphan Drug Designation for Bupivacaine for Post-Herpetic Neuralgia

CUPERTINO, Calif., June 30 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today that the US Food and Drug Administration (FDA) has granted to DURECT orphan drug designation for bupivacaine for relief of persistent pain associated with post-herpetic neuralgia (PHN). Bupivacaine is the active pharmaceutical ingredient in ELADUR(TM), DURECT's investigational transdermal drug patch. If ELADUR is the first bupivacaine product approved for PHN, under the 1983 Orphan Drug Act ELADUR will receive seven years of market exclusivity following the approval of the product by the FDA.


"The receipt of orphan drug status enhances the product opportunity for ELADUR, including providing a more favorable development pathway," stated James E. Brown, DVM, President and CEO of DURECT. "We are continuing to develop ELADUR as a potentially best in class transdermal product for those suffering from PHN."

ELADUR is an investigational transdermal drug patch intended to deliver bupivacaine for up to 3 days 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 for local tissue infiltration, nerve block, and epidural and intrathecal anesthesia. DURECT currently retains full commercial rights to this product candidate.

DURECT has previously announced positive results for ELADUR from a 60 patient Phase IIa clinical trial of patients suffering from post-herpetic neuralgia. In this study, ELADUR showed improved pain control versus placebo during the 3-day continuous treatment period. In addition, ELADUR appeared to be well tolerated overall, and patients treated with ELADUR and placebo exhibited similar safety profiles. A poster describing this study was presented at the 27th Annual Scientific Meeting of the American Pain Society on May 8, 2008 and is accessible on our website (

About DURECT Corporation

DURECT is an emerging specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including Remoxy(TM), POSIDUR(TM), ELADUR(TM), and TRANSDUR(TM)-Sufentanil. DURECT's proprietary oral, transdermal and injectable depot delivery technologies enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs. For more information, please visit

NOTE: ORADUR(TM), POSIDUR(TM), ELADUR(TM) and TRANSDUR(TM) are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. Remoxy, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates under development and have not been 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, its potential to be a best in class transdermal product for those suffering from PHN and its potential to receive seven years of market exclusivity as an orphan drug 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, the risk that ELADUR may not be the first bupivacaine product approved for PHN, 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. Further information regarding these and other risks is included in DURECT's Form 10-Q dated May 8, 2008 under the heading "Risk Factors."

Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. DURECT Announces Positive ELADUR(TM) Phase IIa Study Results
2. Marketing of Diagnostics and deCODEme(TM), Recent Progress in Drug Development to be Highlighted at deCODE R&D Event
3. Pressure BioSciences, Inc. Announces $850,000 NIH SBIR Phase II Award for the Development of a New PCT-dependent System for Improved Biomarker Discovery, Diagnostics, and Drug Discovery
4. Champions Biotechnology Begins Preclinical Development of Its Lead Oncology Drug Candidate
5. GeneGo is Awarded NCI Grant for Development of Systems Biology Platform for Integrative Data Analysis in Cancer
6. Victory Pharma, Inc. Reports MGX006 Enters Into Pivotal Development Program
7. Lilly and TransPharma Medical Announce Licensing and Development Agreement
8. Sunesis Pharmaceuticals Focuses Resources on Development of Voreloxin (Formerly SNS-595)
9. Nektar Announces Expanded Phase 2 Clinical Development Plan For NKTR-102 (PEG-irinotecan)
10. Access Pharmaceuticals Presents Favorable Ovarian Cancer Data and Clinical Update on ProLindac(TM) Development at Prestigious International Symposium
11. BiPar Sciences Expands Clinical Development of BSI-201, A Novel PARP Inhibitor, With Phase 2 Trial in Uterine Cancer
Post Your Comments:
(Date:6/26/2016)... Australia,s successful biotechnology scientists, Dr Graham ... Noxopharm Limited [ABN 50 608 966 123] ("Noxopharm"). Noxopharm is seeking ... ASX. Noxopharm is a clinic-ready company with its first ... study later this year. NOX66 ... cancer patients - the ability of cancers to become resistant to ...
(Date:6/26/2016)... June 27, 2016 Jazz Pharmaceuticals plc (Nasdaq: ... under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as ... Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: CPXX ) ... Daylight Time). As previously announced on May ... definitive merger agreement under which Jazz Pharmaceuticals has commenced ...
(Date:6/26/2016)... -- VMS Rehab Systems, Inc. ( ) reported today ... to build a strong and stable market for trading ... the OTC Markets-pink current trading platform. Explains ... seeing an anomaly in market trading activities that may ... Company, but shareholders and market players as well. I ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A ... 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where the ... history as home to some of the world’s leading providers of cereal and other ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at ... on several important health care topics including advance care planning, healthcare costs and ...
(Date:6/25/2016)... ... 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned ... the David Geffen School of Medicine at UCLA. He trained in Internal Medicine at ... fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all ... brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary ...
Breaking Medicine News(10 mins):