Presented at the 2012 AAPM Annual Meeting « Back

MoxDuo® (Morphine: Oxycodone Combination) Produces Less Oxygen Desaturation than Equianalgesic Doses of Either Morphine or Oxycodone Alone in Subjects with Postoperative Pain Following Bunionectomy

Patricia Richards, MD PhD, patricia.richards@qrxpharma.com¹, Peter Winkle, MD FACG FACP CPI², Richard Paul, MD FACG FACP CPI¹, (1) QRx Pharma Inc., Bedminster, New Jersey, (2) Advanced Clinical Research Institute, Anaheim, California

Introduction: Determine the effect of MoxDuo versus equianalgesic doses morphine and oxycodone on oxygen desaturations (SpO2 <90%) in subjects with acute postoperative pain. Methods: This was a randomized, double-blind study of MoxDuo 12 mg/8 mg q6h versus morphine 24 mg and oxycodone 16 mg q6h following bunionectomy surgery. Subjects ≥18 years of age were ASA class I-III and had moderate-severe pain. SpO2% was measured every 2 seconds over 48 hours with a pulse oximeter. The primary outcome was the AUC of the desaturation events over 48 hours (duration X magnitude of <90% SpO2). Change from baseline in pain intensity was assessed. Results: 375 subjects were enrolled. The AUC was lower with MoxDuo versus morphine and oxycodone for total and most severe desaturations. The median AUC of individual desaturations was 0.012 with MoxDuo, 0.015 with morphine, and 0.022 with oxycodone (p = 0.018, ANCOVA). Among subjects with the worst observed desaturations, the risk was significantly greater with morphine (p<0.009) or oxycodone (p<0.002) versus MoxDuo (4:1 or 5:1 for morphine or oxycodone vs. MoxDuo). The intensity of severe oxygen desaturation was significantly (p<0.05) less with MoxDuo versus morphine or oxycodone. For the worst desaturations, the mean SpO2 value was 53% with oxycodone, 68% with morphine, and 74% with MoxDuo. Mean SPID48 scores were comparable among treatment groups. Conclusion: At equianalgesic doses, oxygen desaturations were shorter and less intense with MoxDuo versus morphine or oxycodone. The respiratory benefits of MoxDuo were demonstrated in a broad population needing opioids for moderate to severe acute pain.

Funding: This work was funded by QRxPharma Inc., Bedminster, New Jersey.