Table 6.
Safety of Oral Naldemedine in Patients with Chronic 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 | |||||
| V9236 – COMPOSE 4 | Katakami et al42 | Phase III. Randomized, double-blind, placebo-controlled study | Nal 97 Placebo 96 |
Nal 0.2 mg OD for 2 wks | Nal 44.3% Placebo 26.0% # (p>0.01) |
Nal 13.4% Placebo 3.1% |
Nal 9.3% Placebo 1.0% (p>0.01) |
NA |
| V9237 – COMPOSE 5 | Katakami et al42 | Phase III. Single-arm, open-label study. (extension study of Study V9236) |
Nal 131* | Nal 0.2 mg OD for 12 wks | Nal 80.2% | Nal 30.5% | Nal 9.2% | NA |
Notes: * Hundred subjects completed 12 weeks of treatment. #In COMPOSE 4 TEAEs is not the primary endpoint.
Abbreviations: Nal, naldemedine; pts, patients; TEAEs, treatment-emergent adverse events.