Suzetrigine, a Non-Opioid NaV1.8 Inhibitor for Treatment of Moderate-to-Severe Acute Pain: Two Phase 3 Randomized Clinical Trials
Authors' conclusion
As compared with placebo, suzetrigine reduced moderate-to-severe acute pain over 48 h after abdominoplasty or bunionectomy. Pain reduction with suzetrigine was similar to that with hydrocodone bitartrate/acetaminophen. Suzetrigine was associated with adverse events that were mild to moderate in severity.
Study context
- Population
- Adults with moderate-to-severe acute pain (verbal categorical rating scale) and NRS ≥4 after abdominoplasty or bunionectomytwo trials · NRS ≥4 after abdominoplasty 1,118 · or bunionectomy 1,073
- Comparison
- Suzetrigine vs hydrocodone bitartrate/acetaminophen vs placebo for 48 h
- Primary endpoint
- Time-weighted sum of the pain intensity difference in NRS from 0 to 48 h (SPID48) vs placebo
- Follow-up
- 0 to 48 h
Methodological detailsdouble-blind, placebo-controlled, active-controlled
- Double-blind
- Placebo-controlled
- Active-controlled
Primary result
As reported in the abstract
SPID48
Suzetrigine vs PlaceboLeast squares mean difference (95% CI)P value
After abdominoplasty
48.4(33.6–63.1)
P < 0.0001After bunionectomy
29.3(14.0–44.6)
P = 0.0002Secondary outcomes
min
| Outcome | Suzetrigine | Placebo | P value |
|---|---|---|---|
| Time to ≥2-point reduction in NRS from baseline vs placebo, abdominoplasty (key secondary)Nominal P | 119 | 480 | P < 0.0001 |
| Time to ≥2-point reduction in NRS from baseline vs placebo, bunionectomy (key secondary)Nominal P | 240 | 480 | P = 0.0016 |
SPID48, suzetrigine vs hydrocodone bitartrate/acetaminophen (key secondary) · 0 to 48 h
- Superiority of suzetrigine not achieved in either trial
Safety
- Adverse events similar to those seen in postsurgical settings
Original publication
Suzetrigine, a Non-Opioid NaV1.8 Inhibitor for Treatment of Moderate-to-Severe Acute Pain: Two Phase 3 Randomized Clinical Trials. Anesthesiology. Published 21 March 2025. doi:10.
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