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:2/5/2016)... WILLIAMSBURG, Va. , Feb. 5, 2016  ivWatch, a ... a Virginia Outstanding STEM Award granted by Governor Terry ... for Science Innovation on February 25th at an event to ... . The STEM award honors professionals and business that ... Logo - http://photos.prnewswire.com/prnh/20160205/330117LOGO ...
(Date:2/5/2016)... Feb. 5, 2016 Aethlon Medical, Inc. (Nasdaq: ... and CEO, will be presenting at Source Capital Group,s 2016 ... NY at 2:15 p.m. ET on Wednesday, February ... Panel discussion taking place at 3:15 p.m. ET. ... one hour after the conclusion of the live event. The ...
(Date:2/5/2016)... India , February 5, 2016 ... a new market research report "Fetal (Labor & Delivery) ... & Antepartum), Warmer, Incubator, Pulse Oximeter, Phototherapy/Jaundice Management Devices, ... published by MarketsandMarkets, This report studies the global market ... market is estimated at USD 6.28 Billion in 2015 ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... The American public tends to feel uncomfortable about ... than regular municipal or well water. The recent experience with lead contaminated water in ... a long way toward increasing public acceptance of recycled waste water as drinking water. ...
(Date:2/5/2016)... ... February 05, 2016 , ... Give To Cure today ... for and donate to Give To Cure’s campaign that is crowdfunding clinical trials to ... make and share payments through a smart device. In 2015 alone, Venmo processed $7.5 ...
(Date:2/5/2016)... ... 05, 2016 , ... Pivot Point Consulting, a leading national ... & Services for HIT Implementation Support & Staffing report with an outstanding score ... by healthcare executives, managers and clinicians representing over 4,500 hospitals and 2,500 clinics. ...
(Date:2/5/2016)... ... February 05, 2016 , ... Dr. Justin Scott and Dr. Lydia ... No Cost Dental Day to individuals in need. The event is scheduled to take ... Cost Dental Day is to provide dental care to community members in need. Each ...
(Date:2/5/2016)... ... February 05, 2016 , ... Dr. Ben Amini, ... it is now welcoming orthodontist, Dr. Amanda Cheng, to the practice. With the ... oral health care, including general dentistry, cosmetic treatments, periodontics, implant dentistry , ...
Breaking Medicine News(10 mins):