Navigation Links
New Drug Application Submitted for Remoxy(TM) (ORADUR(TM)-Based Oxycodone)
Date:6/10/2008

CUPERTINO, Calif., June 10 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today that a New Drug Application (NDA) for Remoxy(TM) (ORADUR(TM)-based oxycodone) has been submitted to the U.S. Food and Drug Administration (FDA). Remoxy, an investigational drug, is a long acting oral formulation of oxycodone intended to treat moderate to severe pain. Based on DURECT's ORADUR technology, Remoxy is designed to resist common methods of prescription drug misuse and abuse.

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

"We are pleased that the first NDA has been filed for a drug candidate using one of DURECT's platform technologies," 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 designed our ORADUR technology to enable the abuse resistant properties of drug candidates such as Remoxy which has the potential to be the first oxycodone on the market that deters common methods of abuse."

Remoxy is being developed by Pain Therapeutics under license from DURECT, and Pain Therapeutics has, in turn, sublicensed the commercialization rights to the drug candidate to King Pharmaceuticals. King and Pain Therapeutics have stated that they believe the NDA for Remoxy benefits from years of rigorous and independent scientific and clinical testing, and the NDA includes animal and human data from extractability, pharmacokinetic, toxicology and clinical studies.

About the NDA for Remoxy (as announced by King and Pain Therapeutics)

Pain Therapeutics submitted the NDA in acc
'/>"/>

SOURCE DURECT Corporation
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5

Related biology technology :

1. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera
2. Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
3. KineMed to Collaborate With Merck KgaA to Validate New Applications for Drug Development Candidates
4. MichBio Announces Expo Tours; Extends Deadline for Innovator Showcase Applications
5. FDA Accepts ISO-Vorin(TM) New Drug Application Amendment Submitted by Spectrum Pharmaceuticals
6. Isis Announces $4.2 Million in Government Contracts Awarded to Its Ibis Subsidiary for Biodefense Applications Development
7. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
8. Nitecs IND Application for Clinical Development With Lodotra Accepted by the FDA
9. CV Therapeutics Submits Supplemental New Drug Application for Ranexa(R) (ranolazine extended-release tablets)
10. National Stem Cell Holding Announces Patent Application for Newly Discovered Cellular Derived Biomaterials for Anti-Aging Applications
11. Laser Energetics to Integrate BrightStar(TM) Alexandrite Lasers in Medical and Dental Applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2013)... May 23, 2013 African ... tracing for people of African descent, today announced ... offering. For people of all races, myDNAmix determines ... five distinct populations: Indigenous Americas (Native American), East ... Subcontinent. , Originally launched in late ...
(Date:5/23/2013)... Missouri (PRWEB) May 23, 2013 ... manufacture of complete thermal systems, recently introduced its ... 90 years of experience in designing and manufacturing ... selection of products to serve diverse customer needs. ... is featured at the beginning of the book. ...
(Date:5/22/2013)... Oven Industries announces the new 5R1-1400 AC ... a PC through the TTL level UART Communication port. ... square can deliver up to 15 AMPS of load ... state relay. Operator safety is achieved with 1KV of ... sensor input. Specifications: Input Voltage 85 to 265VAC ...
(Date:5/22/2013)... MA (PRWEB) May 22, 2013 Cambridge ... present at last week’s “Data Demonstration Day” on Capitol Hill, ... Semantics joined EMC, Google, Microsoft and others to showcase how ... proposed Digital Accountability and Transparency Act (DATA Act). , Originally ... Issa (R-CA) and Sen. Mark Warner ...
Breaking Biology Technology:AfricanAncestry.com Rolls Out Improved MyDNAMix Admixture Test for People of all Races; Enhancements Increase Accuracy in Estimation of Ancestral Makeup 2AfricanAncestry.com Rolls Out Improved MyDNAMix Admixture Test for People of all Races; Enhancements Increase Accuracy in Estimation of Ancestral Makeup 3Watlow Introduces Its New Industrial Heater Catalog 2New AC Temperature Controller Announced by Oven Industries 2Cambridge Semantics Underscores Need for Smart Data during “Data Demonstration Day” on Capitol Hill 2
... Year, East Coast,s Largest Independent Clinical Lab Services ... ... KNOLLS, N.J., Feb. 14 MedeFile,International, Inc. (OTC Bulletin ... management solutions, today announced,that it has signed a collaborative ...
... Department of Veterans Services Partners with New Mexico Tech ... ... The New Mexico,Institute of Mining and Technology (New Mexico Tech) and ... the New Mexico,Department of Veterans Services (DVS) to conduct a $350,000 ...
... 14 BioSpace, the world,s leading,niche online ... the,expansion of its reach to local regional ... parent company, onTargetjobs. With the,inclusion of RegionalHelpWanted.com,s ... boards, BioSpace now offers biotechnology,pharmaceutical, medical device ...
Cached Biology Technology:Hayes Clinical Labs to Market MedeFile's Proprietary Electronic Medical Record Management Solution to Patients 2Hayes Clinical Labs to Market MedeFile's Proprietary Electronic Medical Record Management Solution to Patients 3Hayes Clinical Labs to Market MedeFile's Proprietary Electronic Medical Record Management Solution to Patients 4New Technology for Early Detection of Lung Cancer Selected for Clinical Study With Veterans 2BioSpace.com Strengthens Local Market Candidate Reach Through RegionalHelpWanted.com Acquisition 2BioSpace.com Strengthens Local Market Candidate Reach Through RegionalHelpWanted.com Acquisition 3
(Date:5/23/2013)... the natural history museums of the world are billions ... beetles to flowers, mushrooms and grasses, all stacked, stored ... rich and diverse collections could be critical to understanding ... of a growing human footprint if only the ... brought to life with the help of a team ...
(Date:5/23/2013)... and fastest growing open-access publishers, announces the launch ... and Biotechnology . , A broad scope ... and Biotechnology will provide a single open-access ... research to be disseminated and discussed. , ... provide an open-science and interactive web platform for ...
(Date:5/23/2013)... Neuron , the team reveal the interplay of brain ... by the Wellcome Trust and BBSRC. , By ... improve our perceptual abilities. While these changes can affect ... affect the fidelity of that response. , ... "When you communicate with others, you can make yourself ...
Breaking Biology News(10 mins):CU-Boulder helps tap crowds to digitize museum records of bugs and plants 2CU-Boulder helps tap crowds to digitize museum records of bugs and plants 3CU-Boulder helps tap crowds to digitize museum records of bugs and plants 4Frontiers launches new open-access journal in Bioengineering and Biotechnology 2
... Spanish . The search is on for ... a biologically based approach to controlling silverleaf nightshade, an invasive ... Africa, India, Australia and elsewhere. According to U.S. ... Solanum elaeagnifolium , is being targeted for its ability ...
... (Nov. 24, 2010) -- The bacterial cell is ... compartment with limited internal structure, a primitive cell cycle, ... a new book, Cell Biology of Bacteria , ... distinct intracellular compartments that help orchestrate complex biochemical processes. ...
... Ill. The long, anxious wait for biopsy results ... developed at the University of Illinois. The research ... vibrational imaging (NIVI), on rat breast-cancer cells and tissues. ... tumor boundaries, with more than 99 percent confidence ...
Cached Biology News:Overseas lab seeks US weed control 'recruits' 2New imaging technique accurately finds cancer cells, fast 2New imaging technique accurately finds cancer cells, fast 3
Mature rat whole blood (Sprague-Dawley, averaging 7-8 weeks of age, either sex) is collected at the time of slaughter and processed within 45 minutes. It is then filtered through gauze, pooled in an ...
LAL Chromogenic Endpoint assay...
uncoupling protein 2 (mitochondrial, proton carrier), mRNA (cDNA clone MGC:19567 IMAGE:4335185), complete cds...
Standard 2" or 3" Plastic can be ordered with 81 or 100 cell dividers. Mini 2" Plastics Boxes come standard with 25 cell dividers. Plastic boxes can also be ordered with corresponding freezer racks...
Biology Products: