Table 4.
Safety of Oral Naldemedine in Patients with Chronic Non-Cancer Pain
| Trial | Ref | Phase and Study Design | No of Patients | Treatment | Primary Endpoint | Secondary Endpoints | ||
|---|---|---|---|---|---|---|---|---|
| TEAEs | Serious TEAEs | TEAEs Leading to Discontinuation | TEAEs of Opioid Withdrawal | |||||
| V9231 – COMPOSE 1 | Hale et al37 | Phase III Multicentre, double-blind, randomised, parallel-group trial | Nal 274 Placebo 273 |
Nal 0.2 mg OD for 12 wks | Nal 49% Placebo 45% # |
Nal 5% Placebo 2% |
Nal 1% Placebo 0% |
Nal 1% Placebo <1% |
| V9232 – COMPOSE 2 | Hale et al37 | Phase III. Multicentre, double-blind, randomised, parallel-group trial | Nal 277 Placebo 276 | Nal 0.2 mg OD for 12 wks | Nal 50% Placebo 48% # |
Nal 3% Placebo 5% |
Nal 1% Placebo1% |
Nal 0% Placebo 0% |
| V9235 – COMPOSE 3 | Webster et al38 | Randomized, double-blind, placebo-controlled study. | Nal 621 Placebo 619 | Nal 0.2 mg OD for 52 wks | Nal 68.4% Placebo 72.1% |
Nal 9.7% Placebo 11.8% |
Nal 6.3% Placebo 5.8% |
Nal 1.8% Placebo 1.1% |
| V9238 – COMPOSE 6 | Saito et al39 | Phase III. Single-arm, open-label study | Nal 43 | Nal 0.2 mg OD for 48 wks | Nal 88% | Nal 9% | Nal 7% | NA |
| V9239 – COMPOSE 7 | Saito et al39 | Phase III. Single-arm, open-label study | Nal 10 | Nal 0.2 mg once daily for 48 wks | Nal 90% | Nal 0% | Nal 10% | NA |
Note: #In COMPOSE 1 and 2 TEAEs is not the primary endpoint.
Abbreviations: Nal, naldemedine; TEAEs, treatment-emergent adverse events.