Naldemedine,
does it really help with Improvement of opioid-induced constipation in chronic noncancer pain?
research showsNaldemedine is rated C. Two large placebo-controlled trials increased spontaneous-bowel-movement responders, but all decisive evidence came from the Shionogi development program. Response was 47.6% versus 34.6% in COMPOSE-1 and 52.5% versus 33.6% in COMPOSE-2.
ads claimIt can be marketed like a general laxative, but opioid-induced constipation is a cause-specific condition. Evidence from functional constipation or IBS-C was not used.
Useful facts when choosing a product
- COMPOSE-1 randomized 547 and analyzed 545; COMPOSE-2 randomized 553 and analyzed 550.
- The responder definition required at least three weekly spontaneous bowel movements and at least one above baseline during nine of 12 weeks and three of the final four.
What the research actually shows
COMPOSE-1 randomized 547 and analyzed 545 by intention to treat; response was 47.6% versus 34.6%, difference 13.0 percentage points, 95% CI 4.8 to 21.3, P=0.002, so the primary endpoint succeeded. COMPOSE-2 randomized 553 and analyzed 550; response was 52.5% versus 33.6%, difference 18.9 points, 95% CI 10.8 to 27.0, P<0.0001, also successful. A responder had at least three spontaneous bowel movements weekly and at least one more than baseline for at least nine of 12 weeks and three of the final four weeks. Pain intensity and opioid dose did not worsen clinically, supporting preserved analgesia. Both trials were Shionogi-sponsored. verdict 1573, which is B with 69 points, concerns linaclotide for chronic idiopathic constipation, while verdict 1632, which is B with 70 points, concerns tenapanor for IBS-C; those are different constipation types and their evidence was not transferred.
Why this is classified as C (58)
P, R1, I0, E+, and B0 derive C with 58 points under the single-manufacturer-program ceiling.
Counterpoint. The evidence applies to constipation during stable opioid treatment, not general chronic constipation.
Rejudgment record. Cross-check applied — Two confirmatory trials reproduced sustained spontaneous-bowel-movement response, but all decisive evidence came from one manufacturer program
| Endpoint | P | Patient-reported treatment goal - the symptom is the goal |
| Replication | R1 | Single confirmatory trial |
| Independence | I0 | Evidence comes only from manufacturer studies |
| Effect size | E+ | Meets the clinically important threshold |
The scoring table and the verdict agree (C).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Sustained spontaneous-bowel-movement response over 12 weeks | C | Both confirmatory trials succeeded, but all came from the manufacturer program. |
| Increase in weekly spontaneous bowel movements | C | Multiple manufacturer trials and a meta-analysis were positive. |
| Constipation improvement while preserving analgesia | C | Pain intensity and opioid dose did not worsen clinically. |
Cross-check — Codex and Claude
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Hale M et al. COMPOSE-1, 2017 | Twelve-week multicenter randomized double-blind placebo-controlled phase 3 trial | 545 | Manufacturer sponsorship by Shionogi Inc. with employee coauthors | Proportion of sustained spontaneous-bowel-movement responders | 47.6% versus 34.6%, difference 13.0 points (95% CI 4.8 to 21.3), P=0.002; primary endpoint succeeded | Key confirmatory trial |
| Hale M et al. COMPOSE-2, 2017 | Twelve-week multicenter randomized double-blind placebo-controlled phase 3 trial | 550 | Manufacturer sponsorship by Shionogi Inc. with employee coauthors | Proportion of sustained spontaneous-bowel-movement responders | 52.5% versus 33.6%, difference 18.9 points (95% CI 10.8 to 27.0), P<0.0001; primary endpoint succeeded | Replication within the same program |
Receipt — 2 References
All 2 cited sources were verified for existence at the original page (as of 2026-07-24).
Reviewed and approved: Chamgap Editorial Team · Approval date: 2026-07-24 · Corrections: none
Cite this verdict
[Chamgap] Naldemedine x improvement of opioid-induced constipation — Evidence Grade C·58. 2 cited sources checked. Source: https://chamgap.com/en/verdicts/gut/naldemedine-opioid-induced-constipation-sbm-response/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.