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.
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"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.
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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
