Prolonged-release oxycodone/naloxone in the treatment of neuropathic pain - results from a large observational study.

OBJECTIVES: Opioids have shown consistent efficacy in neuropathic pain, but opioid-induced bowel dysfunction is a relevant problem. In controlled clinical trials, a fixed-dose combination of prolonged-release (PR) oxycodone/PR naloxone was superior to oxycodone alone in bowel function, while providing effective analgesia. The present report is an analysis of its efficacy and safety in a subgroup of patients with severe chronic neuropathic pain who were treated in a large observational study under real-life conditions. RESEARCH DESIGN AND METHODS: Dosed according to pain severity, 1488 patients with chronic severe neuropathic pain received PR oxycodone/PR naloxone for up to 4 weeks. Variables included pain severity, patient-reported bowel function (Bowel Function Index; BFI) and quality of life. RESULTS: During treatment with PR oxycodone/PR naloxone, mean pain intensity decreased in opioid-naive and opioid-pretreated patients. After 4 weeks on treatment, mean BFI scores were reduced from 41.6 ± 31.6 at the initiation visit to 16.5 ± 19.6 (p < 0.001), reflecting normal bowel function. Quality of life was improved by 47%. CONCLUSIONS: Treatment of severe neuropathic pain with PR oxycodone/PR naloxone provided effective analgesia with the added benefit of favorable effects on bowel function and quality of life.