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QRxPharma Releases Additional Phase 3 Data for Q8003IR 'Dual Opioid' Pain Therapy
Date:5/22/2008

surgery and prior to the first 12mg/8mg dose of Q8003IR, the baseline patient pain intensity (PI) scores averaged 6.6 out of 10 units -- with 10 being the most severe on the Numerical Pain Rating Scale. Analgesic effects as reflected in the maximum pain improvement (PI) for the 12mg/8mg dose of Q8003IR yielded a 2 unit reduction of PI (decreasing patient scores to 4.6) versus a 0.14 unit increase of PI for placebo-treated patients. Placebo patients were treated with ibuprofen, a non-opioid analgesic.

The mean time to confirmed perceptible pain relief for Q8003IR was 42 minutes compared to 4.4 hours for placebo. The duration time of analgesic effect was 6.6 hours for Q8003IR versus 2.8 hours for placebo.

The 12mg/8mgdose data demonstrated that Q8003IR was well tolerated, with a low rate of patient withdrawal (8% discontinuing use due to adverse events and 6% discontinuing use due to efficacy failure) compared to placebo (with 2% discontinuing use due to adverse events and 25% discontinuing use for efficacy failure). Only 2% of 12mg/8mg Q8003IR treated patients experienced somnolence, and no incidences of euphoria were reported. The low level of somnolence and absence of euphoria reported were unexpected outcomes compared to what is typically seen with morphine or oxycodone. The significance of these observations will need to be confirmed in future studies that provide a direct data comparison.

All patients exhibited acceptable respiratory rates with reduction in blood oxygen levels occurring in less than 2% of those on the preferred dose of Q8003IR. Typical of opioid drugs, nausea and vomiting were the most common adverse events. Of patients receiving the 12mg/8mg dose, 56% experienced mild to moderate nausea that diminished over the first few hours of treatment; no incidences of severe nausea were reported. 32% of patients reported vomiting with initial dosing (18% mild to moderate and 14% severe). 20% of patients experienced mild to moderate di
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SOURCE QRxPharma
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