FDA Approves Journavx: a New Non-Addictive Pain Medication

3 min read · 6 sections

Opioid medications have long been the standard for the treatment of moderate to severe short-term pain.1 However, while prescription opioids can be used to manage significant pain, they also carry a risk of physiological dependence and addiction, particularly if misused.2 In 2023, more than 5 million people in the United States aged 12 or older had a prescription pain reliever disorder, the diagnostic term for an addiction to prescription painkillers.3 

Given the inherent misuse liability and addictive potential of opioid painkillers, effective alternatives have been conspicuously lacking. The landscape may be changing, however, given the recent approval by the U.S. Food and Drug Administration (FDA) of the non-opioid drug suzetrigine, a new type of pain management medicine that doesn’t carry the risk of addiction or overdose associated with opioids.4

What Is Journavx?

Developed by Vertex Pharmaceuticals, suzetrigine–available under the brand name Journavx–is an oral, non-opioid pain signal inhibitor created to treat moderate to severe acute pain in adults. While the FDA has supported the development of non-opioid pain treatment, Journavx is the first new class of pain medicine to be approved in over 20 years.4,5

How Does Journavx Work?

Journavx blocks the transmission of pain signaling by inhibiting a certain type of sodium channel found in the peripheral nervous system, not in the brain. Through its non-opioid mechanism, suzetrigine can block pain signals from reaching the brain without acting centrally (in the brain) as opioid painkillers do.4 

Opioids work by binding to and activating opioid receptors throughout the brain and spinal cord. In doing so, opioids diminish the body’s perception of pain, which is why they are effective painkillers.

However, opioid pain relief is accompanied by activation of reward circuitry in the brain, which may ultimately lead to changes in mood and thinking, as well as reinforce the continued use of these opioid drugs.2 

The hope is that, as a non-opioid pain medication that acts peripherally instead of in the brain, suzetrigine may avoid opioid-mediated activation of the brain reward centers—which might otherwise make problematic use more likely.

Is Journavx a Safe Alternative to Opioids?

Research suggests that Journavx could help to reshape pain management protocols, offering a safer alternative to opioids for acute pain management. Finding effective ways to treat pain that don’t involve risks of addiction and overdose are key in the ongoing battle against opioid overdose.4 

Two large-scale clinical trials examined the efficacy and safety of suzetrigine. Studies recruited more than 2,000 individuals who were recovering from different surgical procedures. Participants were randomly assigned a placebo (sugar pill), a painkiller combination of the opioid hydrocodone and acetaminophen, or suzetrigine.6

Side Effects and Long-Term Use

Data from these 2 pooled clinical trials have indicated that suzetrigine is generally safe and well-tolerated, with additional phase 3 clinical trial data supporting its safety. Common side effects from the pooled data of these clinical trials included muscle spasms, headache, constipation, nausea, falls, and rash.4,6,7 

Like other medications approved for acute pain management, Journavx should be used for the shortest duration and has not been studied beyond treatment periods greater than 14 days.8

Availability and Cost of Journavx

While initial clinical trial findings for Journavx have been promising, and though the drug may be increasingly available at major national and select regional retail pharmacies throughout the United States, a big concern regarding the medication is the cost. At $15.50 per 50 mg pill, many patients who might benefit from the drug may find the cost of the daily dose, which could be $31 for some, cost-prohibitive.8 

Whether insurance covers Journavx depends on the plan and coverage of brand-name medications, which, currently, this is. Journavx offers financial help for eligible patients with commercial or government-sponsored insurance, such as Medicaid, Medicare, TRICARE, or Veterans Affairs (VA).9

Implications for the Addiction Recovery Community

The approval of Journavx is an exciting addition to the pain management landscape, and it may benefit those in recovery. How? Individuals in recovery from any substance use may be reluctant to take traditional pain medications following an injury or surgical procedure.  

While every person’s recovery looks different, Journavx may offer a non-addicitive pain management solution for those in recovery that doesn’t itself increase the risk of addiction and overdose.

Final Thoughts—A Step Toward Safer Pain Management

The drug’s approval is welcome news to a medical industry eager for access to other non-addictive analgesics beyond suzetrigine. While over-the-counter analgesics such as NSAIDs and acetaminophen may be effective in treating mild to moderate pain, drugs like suzetrigine could prove beneficial in more significant short-term pain management scenarios, such as post-surgical recovery.

Suzetrigine and future medications with novel pain management mechanisms like it may be able to bridge the gap between non-prescription medications and opioids, providing a non-addictive alternative for those wishing to avoid the risks associated with opioid use. These medications could reduce the number of opioid prescriptions healthcare providers write. 

Nevertheless, further research is needed to address cost-related concerns to ensure equitable accessibility to these promising new treatments for pain.

Addiction Treatment for Those Struggling with Opioid Use

Struggling with opioid use and addiction can feel like an endless cycle. But it’s never too late to regain control of your life and start fresh. Seeking professional addiction treatment can open the doors to ongoing support in recovery.

American Addiction Centers (AAC) operates treatment centers throughout the United States–each utilizing evidence-based therapies provided by expert clinicians. Reach out to connect with a compassionate and knowledgeable admissions navigator who can listen to your needs, answer your questions, discuss your options, verify your insurance, and help you begin your recovery journey. 

Not yet ready to talk? You can sign up for 24/7 text support to start a conversation with someone who understands addiction and recovery.

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