The opioid crisis has put physicians in a tough place. Those who alleviate patient suffering through effective acute pain management face significant regulatory hurdles designed to prevent over-prescribing; it’s a delicate balancing act.
Enter Journavx (suzetrigine), the first of a new class of non-opioid pain medicines which received FDA approval in January 2025. As a novel NaV1.8 sodium channel inhibitor, the drug promises to target pain signals in the peripheral nervous system without directly activating central μ-opioid receptors associated with euphoria and respiratory depression.
Physicians on Sermo have shared their thoughts about the pros and cons of the new medication. Learn more about the medication, and what your peers are saying about this potential shift in pain management standards.
Reducing the administrative burden of opioid stewardship
Administrative red tape burdens physicians across specialties. “Certain federal regulations impose unnecessary administrative burdens, detract from clinical care, and do not improve outcomes,” the American Medical Association (AMA) stated in a letter to the White House.
Opioid stewardship, while undeniably critical for public health, has added layers of bureaucracy to clinical workflows. In many states, prescribing a Schedule II opioid requires checking the state’s Prescription Drug Monitoring Program (PDMP), ensuring compliance with specific state laws and often dealing with pharmacy callbacks regarding stock or insurance prior authorizations.
Physicians often wish it wasn’t this way; when asked whether they support the FDA’s designations to expedite the development and approval of safe and effective alternatives to opioids for pain management, a resounding 76% of polled Sermo members said yes.
Journavx isn’t subject to the same regulations as opioids. Because it does not cross the blood-brain barrier in significant amounts and lacks euphoric properties, it is not classified as a controlled substance. This designation means:
- No PDMP checks required: You can prescribe effective pain relief without logging into a separate state database.
- No DEA scheduling limitations: You don’t have the strict quantity and refill limits associated with opioids.
- Streamlined workflow: Prescribing could be simplified compared to prescribing controlled substances.
Sermo members have weighed in on how non-opioid agents such as Journavx fit into their current stewardship models. “Before recommending neuromodulation or cannabinoids, I consider prior treatment response, comorbidities, functional goals, patient preference, and evidence-based safety profiles, ensuring therapies align with clinical need while minimizing potential risks and inequities,” writes one ophthalmologist on Sermo.
Similarly, a general practitioner emphasized a tiered approach: “Opioid stewardship in chronic pain means prioritizing non-opioid treatments, carefully assessing risks, and using opioids only when alternatives fail,” they write. “Neuromodulation or cannabinoid therapies are considered after confirming diagnosis, lack of response to standard care, and thorough patient evaluation, always involving shared decision-making and safety checks.”
Journavx could potentially move from a “when alternatives fail” option to a first-line therapy, simplifying physicians’ decisions.
Journavx and the opioid MDL: How this will affect physicians
The psychological toll of the opioid crisis on physicians is real. The broader medicolegal climate surrounding opioid prescribing stemming from the Opioid Multi-district Litigation (MDL) has made many doctors avoid treating pain aggressively for fear of litigation.
Journavx could mitigate their worries by offering a tool that sits outside opioid regulations. It allows you to treat a patient’s pain without the specific regulatory and prescribing constraints associated with DEA-scheduled opioids.
Sermo members’ discussions suggest that patients are aware of Journavx’s approval, and have begun asking for it by name. “Since Journavx has been approved by the FDA for acute pain, I have been asked by patients if this is a medication option for their chronic pain,” notes one Sermo member. Journavx’s manufacturer Vertex recommends prescriptions don’t exceed 14 days, but “it will be interesting to see if there will be future research for chronic use with its activity at NaV1.8,” the physician adds.
Sermo members are split on whether they think the new pain medication could be a game-changer. In a poll, 50% expressed they think Journavx’s approval is “a really big deal,” while 16% said they don’t, and 31% are still unsure. One “not sure” general practitioner explained their stance: “Chances of dependency on opioids possibly reduce; however, I’m not sure of this current medication’s systemic side effects.”
For surgeons and anesthesiologists, Journavx may become a useful addition to Enhanced Recovery After Surgery (ERAS) protocols. The goal of ERAS is to get patients healthy, mobile and home efficiently, and it’s been shown to reduce complications and cost. Opioids, while effective analgesics, are notorious for longer hospital stays due to side effects like sedation, dizziness, respiratory depression and post-operative nausea and vomiting (PONV).
Journavx works in the peripheral nervous system. By blocking the NaV1.8 sodium channels on nociceptors, it reduces peripheral nociceptor excitability and dampens pain signal transmission. Because it has minimal CNS penetration, patients are more alert and less likely to experience the “fog” associated with narcotics. This facilitates:
- Earlier ambulation: Patients can get up and move sooner, reducing the risk of DVT and pneumonia.
- Gut motility: Without opioid-induced constipation or ileus, dietary advancement happens faster.
- Faster discharge: Fewer adverse events mean a quicker path to discharge criteria.
Sermo polled members on whether they’re optimistic about how Journavx works in the peripheral nervous system, and the majority (65%) said yes.
The latest Journavx trial results, explained
The FDA’s approval of Journavx was largely based on the results of the Phase 3 trials, which utilized the SPID48 (Sum of Pain Intensity Difference over 48 hours) as a primary endpoint.
In these trials, Journavx demonstrated a statistically significant reduction in SPID48 scores compared to placebo following abdominoplasty and bunionectomy surgeries—two procedures known for high levels of post-operative pain. The drug demonstrated clinically meaningful analgesic efficacy compared with placebo.
One of the most critical factors for acute pain is speed. The trials showed meaningful pain relief (defined as a ≥2-point reduction on the numeric rating scale) in as little as 119 minutes for soft-tissue pain. While this isn’t the instantaneous hit of IV medication, it is a viable oral option for maintaining comfort.
It’s important to note that trial protocols allowed for rescue medication (ibuprofen, acetaminophen) for breakthrough pain. This mirrors real-world practice, where multimodal analgesia is the standard.
While the results show promise, some Sermo members remain cautious about the long-term picture. “Longer studies are needed to more clearly identify addictive potential and side effects,” one gastroenterologist writes.
Others highlight access issues that might prevent patients from receiving its benefits. “The majority of my patients have said they found the medication incredibly helpful,” a pain medicine specialist shares on Sermo. “Unfortunately, they were unable to get the medication repeatedly due to the indications and as such, the cost.”
While results are promising, it is worth remembering that other non-opioid pain management options like Celebrex (celecoxib) and gabapentin also showed early promise in reducing reliance on opioids for conditions such as chronic back pain and neuropathy, but subsequent research revealed significant limitations—ranging from cardiovascular risks with prolonged NSAID use to inconsistent efficacy and side effects like dizziness with gabapentinoids—that tempered initial enthusiasm. Ongoing studies for chronic pain applications will be crucial to determine if Journavx avoids the pitfalls encountered by its predecessors.
Common Journavx side effects to consider
While Journavx avoids side effects associated with opioids, it has its own profile to monitor. The pain drug was generally well-tolerated in trials, but physicians should be aware of specific adverse reactions. The most common side effects of Journavx include itching, muscle spasms, increased blood level of creatine phosphokinase and rash. There was no evidence of respiratory depression or sedation—the two side effects that keep hospitalists up at night.
Sermo polled its members on whether they have any concerns about the common adverse reactions in study participants. 53% said yes, 26% responded no and 20% were unsure. While physicians desire opioid alternatives, they are not willing to trade one set of serious health concerns for another. Monitoring for these specific side effects in the early days of adoption will be key.
While the safety profile is strong, Journavx is contraindicated for use with strong CYP3A inhibitors. Additionally, there is a specific warning against grapefruit consumption, as it can interfere with drug metabolism.
Next steps for doctors
Journavx’s emergence doesn’t guarantee an end to opioids. But, it is likely the beginning of a new standard of care for opioid-naïve patients.
Journavx represents a non-narcotic analgesic that could allow physicians to reserve opioids for the most severe, refractory cases. For the average patient undergoing routine surgery or suffering from an acute injury, this could become the new default. The medication’s lack of addictive potential is your strongest talking point for patients concerned about dependency.
Keep in mind that the current indication is for acute pain only. Its role in chronic pain is currently under investigation in Phase 3 trials for diabetic peripheral neuropathy.
Physicians can prescribe Journavx in conjunction with other non-pharmacologic interventions (ice, elevation, PT) and OTC analgesics where appropriate. During trials, participants could take 650 mg of acetaminophen and 400 mg of ibuprofen every six hours for pain relief as needed.
A new era of pain management
The approval of Journavx represents the long-awaited arrival of an opioid alternative with no evidence of opioid-type dependence in clinical trials. While it may not entirely eliminate the need for opioids in all clinical settings, it provides the first major opportunity in a generation to decouple effective pain relief from the risk of dependency.
Have you prescribed Journavx yet? How are your hospital formularies integrating this new class? Join the conversation on Sermo to share your first clinical experiences with Journavx and read other physicians’ perspectives.
