In this review I summarize the ICER 2025 evaluation report of suzetrigine (Journavx®), a new FDA-approved non-opioid oral analgesic. It targets the NaV1.8 sodium channel for moderate-to-severe acute pain. Clinical trials show suzetrigine reduces post-surgical pain better than placebo. It also matches low-dose opioids in pain relief but with fewer side effects like nausea and constipation. Economic modeling suggests Journavx for pain may save costs by lowering opioid use disorder (OUD) risk. Understanding its role in pain management is key for better outcomes.

Background Context  

• Acute pain affects ~80 million U.S. patients yearly. Current treatments rely on opioids and NSAIDs, which carry risks like addiction and organ damage.
• OUD is a public health crisis. In 2022, ~108,000 opioid overdose deaths occurred in the U.S., with 15,000 linked to prescription opioids. The economic cost is tens of billions annually.
• CDC guidelines recommend nonopioid therapies for acute pain. However, safe and effective alternatives are lacking.
• NaV1.8 is a sodium channel in peripheral nerves. It’s a promising target for pain relief without opioid-like CNS effects.
• The FDA approved Journavx for pain in January 2025. It’s the first novel nonopioid analgesic in over 20 years.

Key Insights Driving Suzetrigine´s Value

• Suzetrigine significantly reduced pain more than placebo in post-bunionectomy and abdominoplasty patients. It provided faster relief, especially in abdominoplasty (~2 hours vs. 8 hours for placebo).
• Compared to hydrocodone/acetaminophen (HB5/APAP325), suzetrigine had similar pain reduction. However, opioids worked faster in bunionectomy cases.
• The safety profile is favorable. Adverse events were mostly mild or moderate. Suzetrigine caused less nausea and vomiting than opioids. No respiratory depression or sedation was reported. Long-term safety remains uncertain due to limited trial duration.
• Network meta-analysis suggests suzetrigine matches higher-dose opioids and NSAIDs in efficacy. However, wide confidence intervals indicate uncertainty.
• Economic modeling estimates suzetrigine as cost-saving compared to HB/APAP for one-week treatment. This is due to averting OUD cases, assuming a 0.43% OUD incidence after short opioid use.
• At $232.50 per week, suzetrigine’s budget impact is manageable for healthcare systems.
• Stakeholders stress expanding access to multimodal pain management. They also highlight health equity concerns and the need for more research, including direct comparisons with NSAIDs.

Implications for Health Economics and Outcomes Research

• Suzetrigine could reduce opioid prescriptions, lowering OUD incidence and associated costs.
• Economic models suggest substituting opioids with suzetrigine may be cost-saving. Real-world data will refine these estimates.
• Improved access to suzetrigine may address pain management disparities, especially for underserved groups.
• Payers must balance coverage policies to ensure access while managing costs. Step therapy may not suit acute pain due to the need for rapid relief.
• Future research should compare suzetrigine to high-dose NSAIDs and study high-risk populations.
• Clinicians should update guidelines to include suzetrigine and promote multimodal pain management.

This summary is based on the ICER 2025 final report and integrates clinical, economic, and policy contexts.