Abstract
We evaluated and compared two oral SROs (once-a-day AVINZA® and twice-a-day OxyContin®) in patients with chronic moderate-to-severe low back pain. This was an open-label, randomized, parallel-group multicenter study open to enrollment of SRO-naive subjects, age 30-70, with chronic (≥ 6 months) moderate-to-severe (pain score ’4 on a 0-10 BPI scale) low back pain. A total of 392 subjects were enrolled and underwent opioid dose titration for a period of 3 to 6 weeks. Opioid dose stabilization (pain score< 4 for 3 consecutive days with≤ 2 doses of ibuprofen pain rescue medication per day) was achieved in 266 subjects (132 randomized to AVINZA and 134 to OxyContin) who then entered the 8-week evaluation phase of the study. AVINZA achieved pain control that was significantly better than OxyContin, as demonstrated by a greater decrease from baseline in pain scores evaluated 6, 9, and 12 hours after the morning dose of both opioids (p≤0.02). Subjective sleep parameters assessed by the PSQI were significantly better in the AVINZA group for the entire Evaluation period from Week 1 to 8 (p<0.04). The number of ibuprofen pain rescue medication doses adjusted for the number of patient-days was significantly lower in the AVINZA group (p<0.01). Pain control was achieved with a significantly lower daily opioid dose expressed in morphine-equivalents in the AVINZA group (median of 58 mg and 85 mg, respectively p=0.017). The incidence and severity of elicited opioid side effects was similar in the two treatment groups. This randomized trial showed that AVINZA was significantly better than OxyContin for around-the-clock pain relief and improved sleep, with the added advantage of once-a-day dosing, a lower median morphine-equivalent daily dose, fewer ibuprofen doses for breakthrough pain, and a comparable safety profile. Supported by Ligand Pharmaceuticals Inc, and Organon Pharmaceuticals USA Inc.
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