Required for new drug application (NDA) submission with the FDA, this ‘combination rule’ study compared the efficacy and safety profiles of MoxDuo IR against component doses of Morphine and Oxycodone alone for the management of moderate to severe post-operative pain following bunionectomy surgery.
QrxPharma said that MoxDuo IR not only demonstrated analgesic effect compared to component doses of Morphine and Oxycodone, but also, a favourable side effect profile despite delivering twice the opioid dose of its individual components. The trial enrolled 522 patients at 6 US clinical research sites. Primary and secondary endpoints were met.
In the trail, the primary endpoint for evaluating the efficacy of MoxDuo IR 12mg/8mg versus its milligram components (morphine 12mg and oxycodone 8mg) was the difference in pain intensity scores from baseline for each patient over the 48-hour treatment period (SPID48).
Additionally, secondary endpoints included efficacy relating to the amount of supplemental analgesic (ibuprofen) used throughout the treatment period, difference in pain intensity scores from baseline for each patient over the first 24-hour treatment period (SPID24); and safety as measured by incidence and intensity of opioid-related adverse effects.
John Holaday, managing director and CEO of QrxPharma, said: “While the initial trial data demonstrated the superiority of MoxDuo IR in terms of analgesic effect, further analysis revealed equally important findings in terms of superior overall pain relief, reduced reliance on supplemental analgesia and strong tolerability.
“These findings are consistent with earlier comparative data and reinforce both the clinical benefit and commercial potential of MoxDuo IR, our Dual-Opioid product candidate.
“By delivering twice the opioid dose, one would expect an increase in both the incidence and intensity of a broad range of side effects, but that is not the case with MoxDuo IR.
“Our Dual-Opioid formulation provides pain relief and tolerability as each drug component acts on different receptors. This means we can enhance analgesia without increasing side effects.”