QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced the release of additional data on its Phase 3 safety study for MoxDuo IR. Study 022 compared the respiratory effects of MoxDuo IR to equi-analgesic doses of either morphine or oxycodone in 375 patients experiencing moderate to severe postoperative pain following bunionectomy surgery at 4 US clinical research sites.
A more comprehensive statistical analysis has now been completed that highlights an important clinical advantage of MoxDuo with respect to respiratory depression. In Study 022, respiratory impairment in these patient groups was measured by decreases in blood oxygen levels from the healthy normal range of 96-100% seen at baseline prior to the start of dosing. Oxygen values below 90% (a "desaturation" of hemoglobin) are usually considered clinically significant, and it is widely accepted that the greater the decline in blood oxygen saturation levels and the longer the desaturation lasts, the more severe the clinical outcome if no therapeutic intervention occurs.
To further evaluate such oxygen desaturation, the Company analysed data from patients experiencing the worst (10th percentile) of all observed desaturations. The results demonstrated that the risk of the occurrence of such potentially dangerous desaturations was significantly greater in patients receiving morphine (p