NICE has approved naldemedine as an option for treating opioid-induced constipation in adults after laxative treatment.
The evidence submitted by the company to support the recommendation for naldemedine included findings from four trials (COMPOSE-1, -2, -3 and -4) and three supportive open-label safety studies (COMPOSE-5, -6 and -7).
The primary outcome for COMPOSE-1, -2 and -4 was the proportion of people who had spontaneous bowel movements. For COMPOSE-3, the primary outcome was measures of treatment-emergent adverse events.
The proportion of people who had spontaneous bowel movements was significantly greater in the naldemedine arm compared with placebo for COMPOSE-1, -2 and -4:
- COMPOSE-1: 48 per cent vs 35 per cent (naldemedine vs placebo); percentage change, 13.0 per cent; 95% CI, 4.8 per cent to 21.2 per cent.
- COMPOSE-2: 53 per cent vs 34 per cent; percentage change, 18.9 per cent; 95% CI, 10.8 per cent to 27.0 per cent.
- COMPOSE-4: 71 per cent vs 34 per cent; percentage change, 36.8 per cent; 95% CI, 23.7 per cent to 49.9 per cent.
The cost-effectiveness evidence included naldemedine in several clinical scenarios, for both pure opioid-induced constipation and mixed aetiology constipation. In all scenarios, the most likely cost-effectiveness results were within the NICE thresholds.