Data Demonstrate Dual-Opioid(TM) Provides Significantly Better Pain Relief Compared to Component Doses; Study Goals and Secondary Endpoints Met
QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today the release of additional pivotal Phase 3 trial data for MoxDuo IR, an immediate-release Dual-Opioid pain therapy. Required for New Drug Application (NDA) submission with the United States Food and Drug Administration (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. MoxDuo IR not only demonstrated statistically superior analgesic effect compared to component doses of morphine>
"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," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "These findings are consistent with earlier comparative data and reinforce both the clinical benefit and commercial potential of MoxDuo IR – our lead Dual-Opioid product candidate."
The primary endpoint for evaluating the efficacy of MoxDuo IR 12 mg/8 mg versus its milligram components (morphine 12 mg and oxycodone 8 mg) was the difference in pain intensity scores from baseline for each patient over the 48-hour treatment period (SPID48).
Secondary endpoints included: (1) efficacy relating to the amount of supplemental analgesic (ibuprofen) used throughout the treatment period; (2) difference in pain intensity scores from baseline for each patient over the first 24-hour treatment period (SPID24); and (3) safety as measured by incidence and intensity of opioid-related adverse effects.
In terms of supplemental analgesia, patients in the morphine and oxycodone control groups were 2-3 times more likely to use ibuprofen supplemental dosing than those receiving MoxDuo IR (p<0.05 to p<0.01). Control groups were also more likely to use ibuprofen in greater amounts and earlier in the treatment period than patients receiving MoxDuo IR (p<0.01 to p<0.001). Even with the extra use of rescue medication in the control groups, at both 24 and 48 hours, the amount of pain reduction from baseline was significantly less compared to patients receiving MoxDuo IR (p<0.05 to p<0.001).