Data Support Suzetrigine’s Use for Acute Pain Following Plastic Surgical Procedures

New data from a phase 4 clinical trial (NCT07195669) studying suzetrigine (Journavx; Vertex Pharmaceuticals Incorporated), a prescription nonopioid for the treatment of moderate to severe acute pain in adults, demonstrated the drug’s effective pain management and that it enabled opioid-free recovery after a variety of plastic surgical procedures.^1,2 According to a news release from Vertex Pharmaceuticals, the data were presented at the American Academy of Pain Medicine PainConnect 2026 meeting in Salt Lake City, Utah.¹

What is Suzetrigine?

Suzetrigine is a first-in-class, nonopioid, oral pain signal inhibitor that is selective for NaV1.8 relative to other NaV channels. NaV1.8, a voltage-gated sodium channel selectively expressed in peripheral pain-sensing neurons, transmits pain signals. Because suzetrigine blocks pain signals only in the periphery and not in the brain, it provides effective pain relief without the limitations of certain currently available therapies, including the addictive potential of opioids. The FDA approved the nonopioid on January 30, 2025, as a twice-daily treatment for adults with moderate to severe acute pain, including postoperative pain.^1,3

The treatment’s approval was supported by efficacy data from 2 active and placebo-controlled, double-blind, randomized trials. Participants with moderate to severe acute pain were randomly assigned to receive hydrocodone bitartrate/acetaminophen, suzetrigine, or placebo for 48 hours after either a full abdominoplasty procedure (trial 1; NCT05558410) or bunionectomy (trial 2; NCT05553366). The phase 3 trials measured pain intensity with a patient-reported 11-point numeric pain rating scale, with 0 representing “no pain” and 10 the “worst pain imaginable.” Patients receiving suzetrigine showed a statistically significant reduction in pain compared with those taking a placebo, according to the trial data.⁴

The recommended starting dose of suzetrigine is 100 mg orally, taken on an empty stomach at least 1 hour before or 2 hours after food. Clear liquids, such as apple juice, black coffee, tea, vegetable broth, or water, may be consumed during this time. Tablets should be swallowed whole and not chewed or crushed. Starting 12 hours after the initial dose, the suzetrigine dose is 50 mg orally every 12 hours, with or without food, and adjusted for patients with moderate hepatic impairment or those taking moderate-strength CYP3A inhibitors. Starting 12 hours after the third 50-mg dose, the dosing interval should be extended to 50 mg every 24 hours. Experts recommend that patients with severe hepatic impairment or who are taking strong CYP3A inhibitors not use suzetrigine.⁴

New Data From a Phase 4 Trial

This open-label, multicenter, single-arm phase 4 trial evaluated suzetrigine when administered preoperatively and postoperatively as part of multimodal therapy—most commonly with acetaminophen and ibuprofen—in a range of reconstructive and aesthetic plastic surgeries where patients typically experience moderate to severe pain and are typically treated with opioid therapy for at least 72 hours postoperatively. The study administered treatment to 99 patients who underwent aesthetic and reconstructive surgeries, including reconstructive and aesthetic breast surgeries, liposuction or abdominoplasty with liposuction, and turbinoplasties. The trial’s primary end point was the number of patients who achieved “excellent,” “very good,” or “good” on the Patient Global Assessment scale at the end of treatment.^1,2

According to the data, approximately 90.9% of patients were opioid free through the end of treatment (up to 14 days), reemphasizing the potential for suzetrigine as a core element of opioid-free multimodal treatment for moderate to severe acute pain following aesthetic and reconstructive procedures. In contrast, other evidence suggests opioid-free rates of less than 10% with multimodal treatment without suzetrigine.¹

Further, approximately 90.7% of patients (95% CI, 83.1-95.7%) rated the effectiveness of suzetrigine as part of multimodal treatment as excellent, very good, or good, and 90.9% of patients did not require any rescue opioids after surgery through the end of treatment (up to 14 days). Of the 9 patients who received rescue opioids, the average use was approximately 2 tablets over a 2-day period.¹

Generally, suzetrigine was observed to be safe and well tolerated with no serious adverse events (AEs). Any reported AEs were mild or moderate in severity and consistent with the postoperative setting.¹

“As a surgeon, effective pain management is a cornerstone of patient recovery, and the data from this study highlight the potential of [suzetrigine] in enabling opioid-free recovery for patients across a broad range of surgeries,” lead study author Samuel J. Lin, MD, FACS, director of aesthetic surgery at Beth Israel Deaconess Medical Center, chief of plastic surgery at Beth Israel Deaconess Hospital–Needham, and an associate professor of surgery at Harvard Medical School, said in the news release. “By integrating [suzetrigine] into a multimodal treatment approach, we are not only effectively managing pain but also potentially reducing the risks associated with opioid use, which is a critical advancement for both patients and the broader medical community.”¹

REFERENCES

1. Vertex to present new data on Journavx that demonstrates effective pain management following aesthetic and reconstructive procedures. Vertex Pharmaceuticals Incorporated. News release. March 5, 2026. Accessed March 5, 2026. https://news.vrtx.com/news-releases/news-release-details/vertex-present-new-data-journavxr-demonstrates-effective-pain

2. RCT: suzetrigine vs norco for post-op pain. ClinicalTrials.gov. Updated September 29, 2025. Accessed March 5, 2026. https://clinicaltrials.gov/study/NCT07195669

3. Gallagher A. FDA approves suzetrigine, new alternative to opioids for acute pain. Pharmacy Times. January 30, 2025. Accessed March 5, 2026. https://www.pharmacytimes.com/view/fda-approves-suzetrigine-new-alternative-to-opioids-for-acute-pain

4. Holmberg M. Journavx from Vertex Pharmaceuticals Inc. Pharmacy Times. June 24, 2025. Accessed March 5, 2026. https://www.pharmacytimes.com/view/journavx-from-vertex-pharmaceuticals-inc