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

Abstract

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.

Keywords:

• naloxone
• neuropathic pain
• opioid
• opioid-induced constipation
• oxycodone

Acknowledgements

We are indebted to the physicians who documented the patients in this trial and thank Physicians World Europe GmbH for medical writing assistance. Copyright for the BFI is owned by Mundipharma Research, 2002; the Bowel Function Index is the subject of European Patent Application Publication No. EP 1 860 988 and corresponding patents and applications in other countries.

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