NAVIGATE 1
Trial question
What is the role of suzetrigine in patients with moderate-to-severe acute pain after bunionectomy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
86.0% female
14.0% male
N = 642
642 patients (553 female, 89 male).
Inclusion criteria: adult patients, aged 18-80 years, with moderate-to-severe acute pain after bunionectomy.
Key exclusion criteria: sensory abnormalities or painful physical conditions that might interfere with the patient's ability to assess postoperative pain; long-term use of opioids or NSAIDs.
Interventions
N=426 suzetrigine (at a loading dose of 100 mg, then 50 mg every 12 hours for 48 hours).
N=216 placebo (matching placebo for 48 hours).
Primary outcome
Least squares mean reduction in Sum of Pain Intensity Difference in Numeric Pain Rating Scale at 48 hours
99.9 points
70.6 points
99.9 points
74.9 points
50.0 points
25.0 points
0.0 points
Suzetrigine
Placebo
Significant
increase ▲
Significant increase in least squares mean reduction in Sum of Pain Intensity Difference in Numeric Pain Rating Scale at 48 hours (99.9 points vs. 70.6 points; MD 29.3, 95% CI 14 to 44.6).
Secondary outcomes
Significantly shorter time to ≥ 2 point reduction in Numeric Pain Rating Scale (240 minutes vs. 480 minutes; MD -240, 95% CI -388.61 to -91.39).
Significant increase in good or excellent on the Patient Global Assessment at 48 hours (61.7% vs. 53.2%; AD 8.5%, 95% CI 0.63 to 16.37).
No significant difference in rescue medication use at 48 hours (85.4% vs. 85.6%; ARD -0.2, 95% CI -3.54 to 3.14).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients, aged 18-80 years, with moderate-to-severe acute pain after bunionectomy, suzetrigine was superior to placebo with respect to least squares mean reduction in Sum of Pain Intensity Difference in Numeric Pain Rating Scale at 48 hours.
Reference
Todd Bertoch, Dominick D'Aunno, Jessica McCoun et al. Suzetrigine, a Nonopioid Na V 1.8 Inhibitor for Treatment of Moderate-to-severe Acute Pain: Two Phase 3 Randomized Clinical Trials. Anesthesiology. 2025 Jun 1;142(6):1085-1099.
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