The real-world safety evaluation of the selective NaV1.8 inhibitor suzetrigine: disproportionality analysis and flexible empirical bayes signals from FAERS with external triangulation
Abstract
BACKGROUND: Suzetrigine (Journavx; VX-548), the first selective NaV1.8 voltage-gated sodium channel inhibitor approved by the FDA on 30 January 2025, represents a novel non-opioid option for moderate-to-severe acute pain. Given its recent market entry and unique peripheral mechanism, comprehensive post-marketing safety surveillance is essential.
OBJECTIVE: This study aimed to identify and characterize adverse event signals associated with suzetrigine in the FDA Adverse Event Reporting System (FAERS) using advanced disproportionality and comparator-referenced empirical Bayes (EB) methods, with external triangulation against published literature and WHO VigiBase data.
METHODS: We analyzed FAERS reports through the first 8 months post-approval. Disproportionality metrics (ROR, PRR, IC) were supplemented by a comparator-referenced EB profiling approach that incorporated suzetrigine, acetaminophen, ibuprofen, and background "other drugs," generating 3,000 posterior draws per preferred term (PT). Signals with EB q05 > 2 and no comparator overlap were classified as suzetrigine-unique. High-priority PTs were triangulated with Phase II/III trial data, systematic reviews, case reports, and VigiBase report counts (February 2026).
RESULTS: Of 19 prioritized PTs, 14 were suzetrigine-unique. Dominant clusters included sensory disturbances (paresthesia, burning sensation, skin burning sensation, hypoaesthesia; EB q05 11.43-31.16), musculoskeletal events (muscle spasms EB q05 31.15), and…
Read the paper
Related studies
- Noninvasive and Point-of-Care Surface-Enhanced Raman Scattering (SERS)-Based Breathalyzer for Mass Screening of Coronavirus Disease 2019 (COVID-19) under 5 min
- De Novo Transcriptome Analysis and Detection of Antimicrobial Peptides of the American Cockroach Periplaneta americana (Linnaeus)
- Molecular Characterization and Expression Profiling of Tomato GRF Transcription Factor Family Genes in Response to Abiotic Stresses and Phytohormones
- Assembly of Tight Junction Strands: Claudin-10b and Claudin-3 Form Homo Tetrameric Building Blocks that Polymerise in a Channel-Independent Manner
- Update of the Pompe variant database for the prediction of clinical phenotypes: Novel disease‐associated variants, common sequence variants, and results from newborn screening
- Machine Learning-Based SERS Chemical Space for Two-Way Prediction of Structures and Spectra of Untrained Molecules
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.