QRxPharma Releases Additional Pivotal Phase 3 Combination Rule Study Data for MoxDuo(R)IR in Patients with Post-Sur... (ents (morphine 12 mg and oxycodone 8 mg)...)

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QRxPharma Releases Additional Pivotal Phase 3 Combination Rule Study Data for MoxDuo(R)IR in Patients with Post-Surgical Pain

Date:5/4/2010

ents (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).

The enhanced tolerability of MoxDuo IR seen in earlier studies was further validated in this pivotal Phase 3 combination rule trial. Whilst patients in the MoxDuo IR (12/8mg) arm received twice the morphine equivalent dose of patients in the other two comparator arms (morphine 12 mg or oxycodone 8mg), the incidence and intensity of moderate to severe side effects remains similar whilst efficacy was higher with MoxDuo IR. This tolerability is further evidenced by the 93% to 95% patient completion rate in the study treatment groups.

"By delivering twice the opioid dose, one would expect a substantial increase in both the incidence and intensity of a broad range of side effects, but that is not the case w
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SOURCE QRxPharma
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