Introduction

Suzetrigine, an oral, highly selective Na_V1.8 inhibitor with no addiction potential¹, is approved in the US for moderate-to-severe acute pain management in adults as a new class of non-opioid pain medication. In phase 3 randomized, controlled trials (abdominoplasty/bunionectomy; N=2191), suzetrigine had statistically significant pain relief compared to placebo, with efficacy similar to moderate-opioid therapy.² Here we describe suzetrigine’s effectiveness when initiated preoperatively and administered as part of multimodal therapy (MMT).

Methods

In a phase 4, single-arm study, suzetrigine (100 mg pre-operatively then 50 mg every 12 hours) was administered as part of MMT for treatment of acute pain. Participants (≥18 years) underwent aesthetic/reconstructive surgeries wherein opioids are commonly used ≥72 hours postoperatively for pain management. The protocol was reviewed and approved by an IRB (Advarra, Inc.). Investigators determined MMT, with acetaminophen and/or ibuprofen recommended. The primary endpoint was the proportion of participants reporting good/very good/excellent (patient global assessment) for pain control at the end of treatment (up to 14 days). Safety and opioid rescue were also evaluated.

Results

Participants (N=99) underwent a range of surgeries, including aesthetic breast procedures (33.3%), abdominoplasty with liposuction (28.3%), reconstructive breast procedures (13.1%) and turbinoplasty (13.1%). Most common MMT was suzetrigine with only acetaminophen and/or ibuprofen (78.8%), while 12.1% used suzetrigine alone. Most participants (90.7%) rated effectiveness as good/very good/excellent; effectiveness was consistent across surgery types. Most participants (90.9%) did not require opioid rescue; those who needed opioid rescue received a mean of ~2 tablets through the end of treatment (mean duration: 2.0 days) (Figure 1). Data from the literature on the proportion of patients who are opioid-free after similar procedures will be provided in the presentation, providing context for these results. Suzetrigine was generally safe and well tolerated. Three participants had serious adverse events (bradycardia, pulmonary embolism, angioedema) that were considered not related or unlikely related to suzetrigine. Adverse events that occurred during the study were generally consistent with postoperative settings.

Discussion

Suzetrigine demonstrated highly effective pain management and enabled opioid-free recovery for most (90.9%) participants when initiated preoperatively and as part of MMT after aesthetic/reconstructive surgeries for which opioids are commonly used postoperatively for pain management.