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Background  While opioids provide effective analgesia, opioid‐induced constipation ( OIC ) can severely impact quality of life and treatment compliance. This pooled analysis evaluated the maintenance of efficacy and safety during long‐term treatment with combined oxycodone/naloxone prolonged‐release tablets ( OXN PR ) in adults with moderate‐to‐severe chronic pain.    Methods  Patients ( N  = 474) received open‐label  OXN PR  during 52‐week extension phases of two studies, having completed 12‐week, double‐blind, randomized treatment with oxycodone prolonged‐release tablets (Oxy  PR ) or  OXN PR . Analgesia and bowel function were assessed at each study visit using ‘Average pain over last 24 h scale and Bowel Function Index ( BFI ), respectively. Treatment Satisfaction Questionnaire for Medication was assessed at study end only.    Key Results  Improvement in bowel function was particularly marked in patients who switched from Oxy  PR  in the double‐blind phase to  OXN PR  during the extension phase, resulting in a clinically meaningful reduction (≥12 points) in  BFI  score: at the start of the extension phases, mean ( SD )  BFI  score was 44.3 (28.13), and was 29.8 (26.36) for patients who had received  OXN PR  in the double‐blind phase. One week later,  BFI  scores were similar for the two groups (26.5 [24.40] and 27.5 [25.60], respectively), as was observed throughout the following months. Fewer than 10% of patients received laxatives regularly. Mean 24‐h pain scores were low and stable throughout the extension phases. No unexpected adverse events were observed.    Conclusions & Inferences  Pooled data demonstrate  OXN PR  is an effective long‐term therapy for patients with chronic non‐cancer pain, and can address symptoms of  OIC . No new safety issues were observed which were attributable to the long‐term administration of  OXN PR .

neurogastroenterology and motility

Long‐term evaluation of combined prolonged‐release oxycodone and naloxone in patients with moderate‐to‐severe chronic pain: pooled analysis of extension phases of two Phase III trials