Navigation Links
ELADUR(TM) Development Update: DURECT Receives Orphan Drug Designation for Bupivacaine for Post-Herpetic Neuralgia
Date:6/30/2008

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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)

"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 (http://www.durect.com/wt/durect/page_name/Publications).

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 http://www.durect.com.

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."


'/>"/>
SOURCE DURECT Corporation
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:
*Name:
*Comment:
*Email:
(Date:9/19/2017)... HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, robotically assisted, platform ... leadership team developments today:   ... ... Tom Tefft ... Veteran medical device executive Josh Stopek , PhD, who has led ...
(Date:9/18/2017)... , Sept. 18, 2017 EpiVax, ... of bioinformatics and immune engineering, today announced ... influenza A (H7N9) vaccine. ... to seasonal influenza and presents a challenge ... prior exposure to be effective. Using state-of-the-art ...
(Date:9/12/2017)... N.J. , Sept. 12, 2017  Consumer reviews on the ... Hearing as the number one company for hearing aids, ranking ... and fifteen other brands. ... Embrace Hearing Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides high ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... , ... While it’s often important to take certain medications during the night, ... has identified a solution. , She developed a prototype for MOTION LIGHT-UP PILL BOX ... eliminates the need to turn on a light when taking medication during the night, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of the ... national organization of elder law and special needs planning attorneys. “Membership in ElderCounsel helps ... provides a forum to network with elder law attorneys nationwide,” said Somekh. , ...
(Date:10/13/2017)... ... 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought ... This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at ... towards children of all ages; it is a non-competitive, non-timed event, which is all ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history ... The Brink” is the creation of published author, William Nowers. Captain Nowers and ... WWII veteran, he spent thirty years in the Navy. Following his career as ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... IsoComforter, Inc. ... products, announced today the introduction of an innovative new design of the shoulder pad. ... so you get maximum comfort while controlling your pain while using cold therapy. By ...
Breaking Medicine News(10 mins):