Alexandra R Rola, Jared R Bagley, Emily E Leppien
The recent United States Food and Drug Administration approval of suzetrigine introduces a novel class of analgesics; however, its clinical impact has yet to be defined.
OBJECTIVE: The objective of this study was to review the characteristics, efficacy, and safety of suzetrigine in the treatment of acute pain.
METHODS: Literature was identified using PubMed and clinicaltrials.gov. Search terms included suzetrigine, Journvax, and VX-548, with further limitation to those published in English. Articles selected for inclusion were trials evaluating the safety or efficacy of suzetrigine.
RESULTS: Suzetrigine was evaluated for the treatment of moderate-to-severe acute pain in 2 published phase 2 trials and in 3 unpublished phase 3 trials. All studies report a statistically significant reduction in pain scores. High-dose suzetrigine showed statistically and clinically significant pain reduction vs placebo in abdominoplasty 48.4 (95% confidence interval [CI]: 33.6-63.1; P<0.0001), and bunionectomy 29.3 (95% CI: 14.0-44.6; P=0.0002). Additional unpublished data support potential future use in additional pain indications. Suzetrigine was well tolerated, with pruritus, muscle spasm, constipation, and headache reported as the most common side effects. Suzetrigine is a promising nonopioid alternative for acute pain and is the first of a potential new class of analgesics. However, its comparative efficacy to standard analgesics has not been established, nor has its efficacy when used beyond 14 days.
CONCLUSION: The recent United States Food and Drug Administration approval of suzetrigine introduces a novel class of analgesics; however, its clinical impact has yet to be defined.