Abstract
BACKGROUND: Suzetrigine is a non-opioid, highly selective NaV1.8 pain-signal inhibitor of the voltage-gated sodium channel NaV1.8, with no addiction potential approved in the US for moderate-to-severe acute pain in January 2025.
METHODS: In this phase 4, single-arm study, suzetrigine was administered as part of multimodal therapy (MMT;100-mg preoperatively, then 50-mg q12h) for ≤14days. Patients underwent aesthetic/reconstructive surgeries wherein opioids are commonly used ≥72h postoperatively. Investigators determined MMT, with acetaminophen and/or ibuprofen recommended. The primary endpoint was proportion of patients reporting good/very good/excellent on a patient global assessment (PGA) for pain control at end of treatment. Opioid-rescue and safety were also evaluated.
RESULTS: Patients (N=99) underwent various procedures, the most common being aesthetic and reconstructive breast procedures (33.3% and 13.1%, respectively), abdominoplasty with liposuction (28.3%), and turbinoplasty (13.1%). Most patients (90.7%) rated suzetrigine as part of MMT as good/very good/excellent on a PGA for pain control at end of treatment, which was consistently high across surgeries. Most patients (90.9%) did not require opioid-rescue; those who did received 2.4 tablets (mean) after surgery (mean:2.0days). Most common MMT was suzetrigine with only acetaminophen and/or ibuprofen (78.8%), while 12.1% used suzetrigine alone. Suzetrigine was safe and well-tolerated. Adverse events were consistent with postoperative settings.
CONCLUSIONS: Suzetrigine demonstrated highly effective pain management and enabled opioid-free recovery for most patients (90.9%) when initiated preoperatively and as part of MMT in aesthetic and reconstructive surgeries wherein opioids are commonly used postoperatively; in contrast, in studies of mixed cosmetic procedures in the literature, <10% did not require opioids.