Navigation Links
REMOXY(R) NDA Filing Accepted by FDA and Priority Review Granted
Date:8/12/2008

CUPERTINO, Calif., Aug. 12 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) of REMOXY(R) and granted Priority Review. The FDA typically grants Priority Review to drug candidates that have the potential to demonstrate significant improvements compared to marketed products. The FDA goal for completing review of a drug with Priority Review status is six months from the date the application was submitted. The REMOXY NDA was submitted to the FDA by Pain Therapeutics on June 10, 2008.

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

"We are pleased that the NDA has been accepted and that REMOXY will receive Priority Review," stated James E. Brown, DVM, President and CEO of DURECT. "The abuse of pain medications is a widespread problem in this country and addressing that issue is clearly in the public interest. We're delighted that our ORADUR(TM) technology has enabled the development of REMOXY, an investigational drug that has the potential to be the first oxycodone on the market that deters common methods of abuse."

REMOXY is being developed by Pain Therapeutics (Nasdaq: PTIE) under license from DURECT, and Pain Therapeutics has, in turn, sublicensed the commercialization rights for this drug candidate to King Pharmaceuticals (NYSE: KG). REMOXY, an investigational drug, is a unique, abuse-resistant, controlled release oxycodone for moderate-to-severe chronic pain.

About ORADUR(TM) Technology

ORADUR is a proprietary technology designed to transform short-acting oral capsule dosage forms into sustained release oral products, with the added benefit of being less prone to abuse (e.g. by crushing or water extraction) than other controlled release dosage forms on the market today.

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(R), 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 REMOXY, its attributes, the timing of FDA review of the NDA and its potential to be the first oxycodone on the market that deters common methods of abuse 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 potential that FDA may not grant regulatory approval of REMOXY, difficulties or delays in the development, testing, regulatory approval, production and commercialization of REMOXY, and unexpected adverse side-effects or inadequate therapeutic efficacy of REMOXY that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials). Further information regarding these and other risks is included in DURECT's Form 10-Q dated August 8, 2008 under the heading "Risk Factors."


'/>"/>
SOURCE DURECT Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Lixte Biotechnology Holdings Announces Filing of a New Patent Application for the Use of Novel Compounds as Potential Treatment for Neurodegenerative Diseases
2. CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)
3. Embryo Viability Studies Support Utility of Novel, Metabolomic Profiling Technology
4. ISTA Pharmaceuticals Announces New Phase III Clinical Findings to Support Bepreve NDA Filing
5. Preclinical Study Shows CTIs Brostallicins Cancer-Killing Ability Based on Genetic Profiling
6. Oncology Drug Development Update - Molecular Profiling Redefines the Nature of Malignancy and Increases the Adoption of Targeted Therapeutics
7. Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia
8. Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System
9. Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA
10. Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B
11. Wyeth Presents New Phase 3 Data and Updates Regulatory Timing for NDA Filing of Bazedoxifene/Conjugated Estrogens
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016  American Respiratory Labs (ARL), a ... now able to perform sophisticated lung assessments in patients, homes, thanks ... Inc. Patients are no longer limited to having ... PRO ® , ARL patients like Jeanne R. of ... the comfort of her own home. ...
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ... company developing innovative inhaled drugs, announced today that it ... Russell Investments reconstituted its comprehensive set of U.S. ... "This is an important milestone for Pulmatrix," said ... increase shareholder awareness of our progress in developing drugs ...
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... 2016 , ... Today, MTI-GlobalStem, a provider of optimized transfection ... to transfect cells, announces its launch of the PluriQ™ G9™ Gene Editing System ... is a complete system for culturing and transfecting human pluripotent stem cells for ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... and infrastructure. Most providers, however, are unsure how to move forward, given the ... to define a path forward tailored to an organization’s specific needs. , PYA ...
(Date:6/24/2016)... ... ... SpiritQuest Sedona Retreats, located in Arizona has re-located to 75 Kallof Place, ... Rock, Airport Mesa, and Boynton Canyon. The new retreat center is ideally-situated ... the Sedona Rouge, both popular accommodations for SpiritQuest clients. The Medicine Wheel, Labyrinth ...
(Date:6/23/2016)... ... 2016 , ... An article published June 8 on AOL News ... neck cancer in individuals with unhealthy oral hygiene habits. The article goes on to ... had gum disease, brushed their teeth on a daily basis, wore dentures and if ...
(Date:6/23/2016)... ... June 23, 2016 , ... SyncDog, Inc. ... mobile security software, is featured in the current issue of Silicon Review ... companies with innovative technology solutions and features them in their magazine. The magazine ...
Breaking Medicine News(10 mins):