BHI Core Faculty members Drs. Tibor Rohacs and Ying-Xian Pan shared their insights on recent news about the FDA’s approval of a new non-opioid painkiller from Vertex Pharmaceuticals. The drug, Journavx (suzetrigine), has been approved for the treatment of moderate to severe acute pain in adults.
Tibor Rohacs, PhD
Professor, Department of Pharmacology, Physiology & Neuroscience, Rutgers New Jersey Medical School
Vice-Chair of the Cognitive and Sensory Neuroscience Focus Area Working Group (CSN-FAWG)
BHI Core Faculty
The FDA’s recent approval of suzetrigine (Journavx™)—a voltage-gated sodium channel blocker developed by Vertex Pharmaceuticals to treat acute pain—marks an important milestone in the search for safer, more effective analgesics. Historically, severe pain has been managed either with opioids, which carry a high risk of addiction and other side effects, or with over-the-counter medications such as ibuprofen (Motrin) and acetaminophen (Tylenol), which often fail to provide sufficient relief for high-intensity pain. Voltage-gated sodium channels, particularly those expressed in peripheral sensory neurons—such as Nav1.8, the specific target of suzetrigine—have emerged as promising alternative targets. By reducing or blocking the neuronal excitability that drives pain transmission, these novel sodium channel blockers may deliver substantial analgesic benefits with fewer systemic risks.
Suzetrigine’s approval is especially notable because it is the first FDA-approved sodium channel blocker for pain. In clinical trials, it demonstrated analgesic effects on par with a low-dose opioid in acute pain settings (such as bunion surgery), though it performed only as well as placebo in treating chronic sciatica. Nevertheless, suzetrigine’s debut may pave the way for future voltage-gated sodium channel blockers with greater efficacy in persistent pain states. Other subtypes, such as Nav1.7, also show considerable promise, given the unique phenotype of individuals with loss-of-function mutations in this channel, who are completely insensitive to pain—even though no clinically effective Nav1.7 inhibitor has been developed to date. As research accelerates, the therapeutic landscape for chronic pain may shift significantly, offering new hope to both patients and clinicians.
Ying-Xian Pan, MD, PhD
Professor, Department of Anesthesiology, Rutgers New Jersey Medical School
BHI Core Faculty
Mu opioids have long been the mainstream for treating moderate to severe pain in clinic, despite for their adverse side-effects, such as tolerance, dependence and addiction. Although tremendous efforts have been made to develop novel opioid analgesics without these side effects, few was approved by FDA. In recent years, developing new non-opioid analgesics has emerged as an important alternative strategy for therapeutic development of safer pain medication. The FDA approval of Journavx (suzetrigine or VX-548) made by Vertex Pharmaceuticals on January 30, 2025, represents a significant milestone for research and development of non-opioid analgesics. It is not entirely surprising that Journavx can relieve pain without addictive potential because it targets a peripherally expressed voltage-gated sodium channel (Nav1.8). Yet, it is impressive that Journavx has showed efficient analgesic efficacy for moderate to severe acute pain, mainly in postoperative pain, but not in diabetic neuropathic pain, which is comparable to the combination of hydrocodone, a mu opioid, with Tylenol. Thus, Journavx provides an effective alternative to opioid for pain management. It will be interesting in seeing its analgesic effect or side effects as more clinical data become available.
In addition to Journavx, several other Nav1.8 inhibitors have been developed, one of which is currently under Clinical trials (NIH UG3DA058552-01). Developing an antibody against voltage-gated sodium channels, including Nav1.7, Nav1.8 and Nav1.9 is also underway (R61NS127285-01), although still at the preclinical stage. Both studies are supported by NIH Helping to End Addiction Long-term (HEAL) Initiative. The HEAL initiative has funded over 1,800 research projects with ~3.0 billion since 2018. One major goal of the HEAL initiative is to develop novel non-opioid pain medication for combating opioid epidemic. Besides voltage-gated sodium channels, other non-opioid targets, such as cyclic nucleotide-regulated channels, cannabinoid receptor, metabotropic glutamate (mGlu) receptor, mitogen-activated protein kinases, Neurokinin-1 receptor and cholecystokinin B receptor (CCKBR), have been established with the support from the HEAL initiative for the development of non-opioid analgesics against various types of pain without adverse side effects associated with mu opioids. We are optimistic and anticipate that several new non-opioid pain medications will be approved by FDA in the coming years, providing safer and diverse alternatives for better pain management in clinic.
