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:7/21/2017)...  Endo International plc (NASDAQ: ENDP ) ... its manufacturing network, the Company will be ceasing operations ... Huntsville, Alabama . The closure of the ... 12 to 18 months. The Huntsville ... commoditized products and these restructuring actions are intended to ...
(Date:7/17/2017)... 17, 2017  MedX Holdings, Inc., the manufacturer and ... and rehabilitation equipment, today announced the national roll out ... considered the gold standard for the treatment of low ... strengthening equipment. How ... physician or practice who prescribe the MedX Home Back ...
(Date:7/13/2017)... , July 13, 2017  Centurion Medical Products, a leader in ... DisImpactor ® fecal impaction removal device for hospice patient care. ... Centurion Medical ... Patient pain management and emotional comfort ... can help alleviate patient pain while preventing unneeded emergency department admission ...
Breaking Medicine Technology:
(Date:7/23/2017)... ... , ... Scientists from the University of Exeter reported this month ... equivalent to a medium-paced run for pre-menopausal women, or a slow jog for post-menopausal ... spine care, I understand the importance exercise can play on improving bone health. Although ...
(Date:7/23/2017)... LA (PRWEB) , ... July 23, 2017 , ... ... to interact, thus improving communication, safety and patient-provider relationships. New tools are helping ... to results of the 19th Annual Health Care’s Most Wired® survey, released today ...
(Date:7/23/2017)... ... ... “Squiggy’s Outdoor Adventure”: a turtle’s backyard adventure that teaches the importance of ... Christian, a wife and mother to three amazing, and supportive, children. Paula lives ... God. She loves to tell stories to her children, play board games, bake, ...
(Date:7/22/2017)... ... July 22, 2017 , ... More ... majority of patients not requiring pain medication after three months post-operatively. However, researchers ... Annual Meeting today in Toronto, Ontario, Canada found that those patients who were ...
(Date:7/21/2017)... ... July 21, 2017 , ... The Bryant Agency, ... families and business owners in the Dalton region, is working in conjunction with ... sexual assault and physical abuse. , The GreenHouse is headquartered in Dalton and ...
Breaking Medicine News(10 mins):