A study of AVINZA (morphine sulfate extended-release capsules) for chronic moderate-to-severe noncancer pain conducted under real-world treatment conditions--the ACCPT Study.

This study evaluated the clinical effects and pattern of use of AVINZA((r)), morphine sulfate extended-release tablets, under real-world treatment conditions. Opioid-naive subjects or subjects who have failed other opioids were eligible if they had chronic moderate-to-severe noncancer pain with an average pain score > or =4 (0-10 scale) in the preceding month. Subjects answered in-depth monthly questionnaires in three months. For the 491 evaluable subjects enrolled, the median AVINZA dose was 30 mg at baseline, titrated to 60 mg by month 1, and remained at 60 mg through month 3. Adherence was high, with almost 90% of the subjects reporting never having forgotten to take AVINZA. Mean daily pain scores (scale 0-10) significantly improved from 7.83 at enrollment to 5.77 at month 1 (P < 0.01) and then remained at this level through month 3. Significant improvements were seen in all sleep measures, and the mean Composite Sleep Score, a global measure of sleep quality (scale 0-10), significantly improved from 5.73 at baseline to 4.96 at month 3 (P < 0.01). Physical functioning was improved for activities requiring a moderate effort (P = 0.053), such as climbing one flight of stairs (P = 0.008). Two hospitalizations for nausea and vomiting were the only reported drug-related serious adverse events. This study showed that once-daily AVINZA significantly reduced pain scores, and resulted in improved sleep and physical functioning in patients with chronic moderate-to-severe pain. These results were achieved with a stable daily morphine dose over the three-month study period.