Navigation Links
QRxPharma Initiates Comparative Phase 2 Proof-of-Concept Study for MoxDuo(TM) IV Pain Therapy
Date:7/23/2009

Efficacy and Safety Study in Patients with Moderate to Severe Post-Operative Pain

SYDNEY, Australia and BEDMINSTER, N.J., July 23 /PRNewswire-FirstCall/ -- QRxPharma Limited (Pink Sheets: QRXPY; ASX: QRX) announced today the initiation of a Phase 2 comparative proof-of-concept study to evaluate the efficacy and safety of MoxDuo(TM) IV (intravenous morphine and oxycodone) versus IV morphine alone for the treatment of moderate to severe post-operative pain in patients following hip replacement surgery. Data from this study will serve as a significant predictor of MoxDuo(TM) IV's clinical benefits and provide guidance for the design of further clinical trials leading to submission of an NDA to the US Food and Drug Administration (FDA) within the next three years.

"QRxPharma's goal is to bring to market complementary analgesic options for pain specialists, delivering greater patient tolerability and efficacy than current standards of care. MoxDuo(TM) IV is one of three Dual-Opioid(TM) products that also include immediate-release (IR) and controlled release (CR) oral formulations," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma.

QRxPharma's MoxDuo(TM) products are the only combination opioids in commercial development. Extensive clinical studies have shown Dual-Opioids(TM) to provide better pain relief with significantly fewer side effects.

This double blind, active controlled study will determine: (1) whether MoxDuo(TM) IV has fewer opioid-related adverse events than morphine alone at equianalgesic doses and (2) whether the maximum analgesic effect of MoxDuo(TM) IV is superior to morphine alone.

The study is being conducted at the Cologne-Merheim Medical Center, a part of Witten/Herdecke University, and Cologne University Hospital, both in Cologne, Germany.

"I am pleased to be conducting this study of MoxDuo(TM) IV with QRxPharma," said Professor Dr. Edmund Neugebauer, Chair of Surgical Research at the Institute of Research in Operative Medicine. "I am optimistic that MoxDuo(TM) IV will enable doctors to provide better pain relief with fewer side effects, getting patients on their feet earlier than with existing opioid pain medications."

Following hip replacement surgery, 40 subjects will be randomised into MoxDuo(TM) IV or morphine IV groups over a two-part, 48-hour treatment period. In Part 1, rapid dosing will be used by the physician to achieve maximal reductions in pain. In Part 2, patients will manage their own pain relief on an "as needed" basis using self-administered PCA (patient controlled analgesia). The MoxDuo(TM) IV and morphine groups will be compared for clinically significant differences in analgesia and/or side effects.

"Preliminary Phase 3 data demonstrate that the Company's MoxDuo(TM) IR oral formulation consistently yields superior pain relief with a lower frequency of side effects than morphine and oxycodone alone. We believe our intravenous formulation will demonstrate similar benefits as seen with orally administered MoxDuo(TM) IR," said Dr. Holaday. "Specifically, the absence of sedation as well as reduced nausea and vomiting may permit accelerated patient recovery while providing superior pain relief. This will enable physical therapy to begin sooner, saving time and money for both patient and payer."

QRxPharma expects the study to be completed before the end of 2009.

Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of QRxPharma as of the date of this release. These forward-looking statements are not guarantees for future performance. Actual results could differ materially from those currently anticipated due to a number of factors including risks relating to the stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialisation of the

Company's proposed products.

About QRxPharma

QRxPharma (ASX: QRX and OTCQX: QRXPY) is a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management and central nervous system (CNS) disorders. Based on a development strategy which focuses on enhancing and expanding the clinical utility of currently marketed compounds, the Company's product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. The Company intends to directly commercialise its products in the US and seek strategic partnerships abroad. QRxPharma's lead compound, MoxDuo(TM) IR , successfully completed a Phase 3 study and met primary and secondary endpoints. The Company's preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics. For more information, please visit www.QRxPharma.com.


'/>"/>
SOURCE QRxPharma Limited
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. QRxPharma Initiates Second Comparative Study for MoxDuo(TM) IR Dual-Opioid(TM) Pain Therapy
2. QRxPharma Initiates Comparative Study for MoxDuoIR(TM) Dual-Opioid(TM) Pain Therapy
3. Sinovac Initiates Dosing in Human Clinical Trial of Panflu for Pandemic Influenza A (H1N1)
4. Lexicon Initiates Phase 2 Clinical Trial of LX1032 in Patients With Carcinoid Syndrome
5. Aegera Initiates Phase 2 Clinical Trial Of AEG33773 - A Small Molecule Targeting Neuropathic Pain
6. Evoke Pharma, Inc. Initiates Phase 2b Metoclopramide Intranasal Trial (MINT) in Patients With Diabetic Gastroparesis
7. Sinovac Initiates Preparatory Activities for Swine Flu Vaccine
8. Medicago initiates work on Swine Flu strain
9. Amira Initiates Phase I Clinical Trial of Novel DP2 Antagonist
10. Masimo Initiates Full Market Release of First-Ever Noninvasive Continuous Hemoglobin Monitor
11. Nereus Pharmaceuticals Initiates ADVANCE, a Randomized Phase 2 Clinical Trial of NPI-2358 in Non-Small Cell Lung Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... and GERMANTOWN, Maryland , ... Frankfurt Prime Standard: QIA) today announced the introduction of ... gene expression profiling, expanding QIAGEN,s portfolio of Sample to ... researchers to select from over 20,000 human genes and ... between genes, cellular phenotypes and disease processes. --> ...
(Date:2/11/2016)... , Feb. 11, 2016  Spectra BioPharma Selling ... (CSO) that provides biopharma companies the experience, expertise, ... and deploy outsourced sales teams. Created in concert ... addresses both the strategic and tactical needs of ... sales solutions through both personal and non-personal promotion. ...
(Date:2/11/2016)... ... February 11, 2016 , ... ... cutting-edge information focused on the development and manufacture of biopharmaceuticals and therapeutics, ... sponsor of the 2016 BioProcess International Awards – Recognizing Excellence in the ...
(Date:2/11/2016)... , February 11, 2016 ... ("PositiveID" or "Company") (OTCQB: PSID), a life sciences ... that its Thermomedics subsidiary, which markets the Caregiver® ... growth plan in January 2016, including entering into ... sequential monthly sales growth, and establishing several near-term ...
Breaking Biology Technology:
(Date:1/25/2016)... 2016  Glencoe Software, the world-leading supplier of image ... will provide the data management solution OMERO Plus for ... Photo - ... Phenotypic analysis measures the characteristics and behavior ... between states such as health and disease, the presence ...
(Date:1/22/2016)... http://www.researchandmarkets.com/research/p74whf/global_biometrics ) ... "Global Biometrics Market in Retail Sector 2016-2020" ... --> http://www.researchandmarkets.com/research/p74whf/global_biometrics ) has announced the ... in Retail Sector 2016-2020" report to ... and Markets ( http://www.researchandmarkets.com/research/p74whf/global_biometrics ) has announced ...
(Date:1/20/2016)... -- A market that just keeps on growing. Molecular ... in genomics knowledge. Learn all about it in this ... dynamic trends are pushing market growth and company valuations. ... - pathogen evolution - next generation sequencing - emergence ... of the role of genetic material in Disease and ...
Breaking Biology News(10 mins):