NICE approves naldemedine for opioid-induced constipation

  • National Institute for Health and Care Excellence
  • 27 Aug 2020

  • curated by Dawn O'Shea
  • UK Medical News
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

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.