A year after its approval, questions remain about the non-opioid therapy Journavx

One year after the approval of Journavx (suzetrigine), a first-in-class non-opioid therapy for acute pain, the question facing clinicians and payers is no longer what the drug is but where it fits.

Approved by the FDA in January 2025, Journavx is the first new type of acute pain medicine in more than 20 years. The drug works by blocking the NaV1.8 voltage-gated sodium channel, which is mainly found in nerve fibers that sense pain.

By acting on nerves outside the brain and heart, the drug could avoid the sedation, cognitive problems and addiction risks linked to opioids. It represents a first systemic sodium channel blocker that could expand the limited treatment options available for acute pain. Its oral, twice-daily tablets make it suitable for pain management and it could have a role in non-surgical acute pain as well.

The drug’s FDA approval was based on clinical trials in adults undergoing abdominoplasty or bunionectomy. Journavx reduced pain more than placebo and worked faster in producing relief. It also caused less nausea and vomiting than a standard combination of hydrocodone and acetaminophen.

However, it didn’t outperform opioids overall, and many patients still needed ibuprofen to manage the pain completely. Past studies in non-surgical pain suggest it may help conditions such as back, limb or facial pain, with more than 90% of participants reporting positive results.

These findings are promising but limited and seem to need more testing before broader approval.

Experts have more recently been saying that Journavx’s bigger impact may not be immediate results but its role in moving pain care toward non-opioid options. Brian F. Mandell, M.D., Ph.D., editor-in-chief of the Cleveland Clinic Journal of Medicine, pointed out that even with tighter rules on opioids, patients still need strong pain relief. He also highlighted that Journavx works on sodium channels in peripheral pain-sensing nerves rather than the central nervous system, a feature that could reduce risks like addiction and cognitive side effects.

Uncertainty still limits wide adoption, however. For instance, clinical trials were small and mostly included similar patients, leaving questions about real-world effectiveness in more diverse or complex populations. Long-term safety is also unknown, including effects on tolerance, chronic use or rare side effects.

While the new therapy caused less nausea than opioids, it has yet to prove it can reduce opioid use.

Cost and coverage could also affect uptake. At roughly $15 per pill, Journavx could face scrutiny from payers deciding if it’s worth the price compared to standard opioids or non-steroidal drugs.

Plans could require prior authorization or step therapy, which can limit access. However, millions of patients could benefit, from those recovering from surgery to those with acute injuries or illnesses. Even limited use of this higher-cost drug could affect healthcare spending, especially if it is included in multimodal pain strategies.

After a year on the market, Journavx does not seem like a universal solution yet, but it still represents a new option for acute pain management. Its targeted functioning and generally good tolerability suggest it could be used alongside other pain treatments in both postoperative and nonsurgical settings.

Future real-world studies and phase 4 trials could be important to show how it performs in everyday practice, how it affects opioid use and patient outcomes and how it could influence coverage and costs.