QRxPharma has initiated a phase 2 comparative proof-of-concept study to evaluate the efficacy and safety of MoxDuo IV (intravenous morphine and oxycodone) versus IV morphine alone. It is for the treatment of moderate to severe postoperative pain in patients following hip replacement surgery.
Data from this study will serve as a significant predictor of MoxDuo IV’s clinical benefits and provide guidance for the design of further clinical trials, leading to submission of an NDA within the next three years.
This double blind, active controlled study will determine, whether MoxDuo IV has fewer opioid-related adverse events than morphine alone at equianalgesic doses, and whether the maximum analgesic effect of MoxDuo IV is superior to morphine alone.
Following hip replacement surgery, 40 subjects will be randomised into MoxDuo 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 MoxDuoIV and morphine groups will be compared for clinically significant differences in analgesia and/or side effects. The company expects the study to be completed before the end of 2009.
John Holaday, managing director and CEO of QrxPharma, said: “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 IV is one of three Dual-Opioid products that also include immediaterelease (IR) and controlled release (CR) oral formulations.”
“Preliminary Phase 3 data demonstrate that the Company’s MoxDuo IR oral formulation consistently yield 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 IR. Specifically, the absence of sedation as well as reduced nausea and vomiting may permit accelerated patient recovery while providing superior pain relief, he added.