Pain relief without addiction? FDA approves first non-opioid alternative in decades
- Neave Smith
- May 16
- 4 min read
On 30th January 2025, the U.S. Food and Drug Administration (FDA) approved Journavx™ (Suzetrigine) 50mg oral tablets for use in the treatment of moderate to severe acute pain. This approval has marked the introduction of a new class of pain management drugs; the first to receive federal approval in over twenty years.
The Opioid Dilemma
For decades, opioid medications like morphine, fentanyl, and codeine have been the gold standard for pain relief. These drugs work by binding to opioid receptors in the central and peripheral nervous system, effectively reducing pain perception. However, long-term use comes with significant risks: tolerance, dependence, respiratory depression, and even opioid-induced hyperalgesia, where prolonged use paradoxically heightens pain sensitivity.
The opioid crisis remains a critical public health emergency, particularly in North America, where synthetic opioids like fentanyl continue to drive high overdose rates. In 2022 alone, synthetic opioids were responsible for 68% of the 108,000 overdose fatalities in the U.S. As the crisis continues to devastate lives and communities, the demand for safer, non-addictive pain relief solutions has never been more urgent.
How Suzetrigine Works: A New Approach to Pain Relief
Suzetrigine provides pain relief through a highly selective inhibition of the NaV1.8 channel, offering an alternative to opioid-based treatments, without the risk of addiction. Unlike opioid receptors, the NaV1.8 channel is not expressed in the central nervous system so does not produce any of the centrally mediated side-effects associated with current analgesics. Instead, it plays a crucial role in pain signal transmission in dorsal root ganglion (DRG) sensory neurones. By stabilising the closed state of this channel, Suzetrigine effectively reduces pain signals without engaging the pathways responsible for opioid dependence, making it a promising non-addictive analgesic option.
Clinical Trials: How Effective is Suzetrigine?
In Phase III clinical trials, Suzetrigine significantly reduced pain compared to a placebo, particularly among patients recovering from abdominoplasty and bunionectomy surgeries. The treatment demonstrated good tolerability and a strong safety profile. Unlike opioids, Suzetrigine is non-addictive and does not cause nausea or drowsiness - two common side effects of opioid medications.
The most frequently reported adverse effects were mild, including itching, muscle spasms, and rash. However, when directly compared to hydrocodone bitartrate/acetaminophen (HB/APAP), a widely used opioid combination, Suzetrigine was found to be less effective in terms of pain relief. Despite this, its non-opioid, non-addictive nature positions Suzetrigine as a compelling alternative in the ongoing effort to develop safer pain management therapies.
The Challenge of Bringing a new Non-Opioid Pain Medication to Market
Pain management today is dominated by cheap, highly effective opioid medications that are easy to access. According to Biopharma Dive, many U.S. doctors believe the biggest barrier to prescribing Journavx will be insurance coverage. Insurers often resist paying for new, higher-cost medications, making it difficult for innovative treatments to gain traction.
Vertex has set the price of Suzetrigine at $31 per day for patients - a steep contrast to generic opioids, which can cost as little as $0.50 per day. This substantial price gap may hinder adoption, unless policy changes and advocacy efforts push for broader coverage of non-opioid alternatives.
The Path Forward
To overcome these barriers, three key changes are needed:
Robust clinical data proving long-term benefits over opioids.
Policy advocacy to push for insurance coverage of safer pain relief options.
A shift in prescribing habits, encouraging healthcare providers to prioritise non-addictive medications.
Chronic Pain Treatment: Can Suzetrigine Help?
While Suzetrigine has been approved for acute pain, its role in chronic pain management remains uncertain. Chronic pain, defined as pain lasting longer than three months, affects one-third to one-half of the UK population and is the leading cause of disability worldwide. Despite guidelines advising against opioid use for chronic primary pain, 24% of individuals with chronic pain still rely on opioid painkillers.
Suzetrigine has undergone Phase II clinical trials for chronic pain conditions, such as sciatica-related nerve pain, but the results have been mixed. While there was some pain reduction over 12 weeks, the benefits were not significantly better than a placebo. As a result, Suzetrigine is currently approved only for short-term, acute pain relief, with further research needed to establish its potential in chronic pain management.
Final Thoughts
The approval of Journavx™ (Suzetrigine) represents a significant milestone in the advancement of non-opioid pain relief. Future formulations or combination therapies may further enhance its efficacy, while ongoing research could determine its effectiveness for specific types of pain or patient populations. Although challenges remain - particularly with insurance coverage and cost - this innovation marks a crucial step toward reducing opioid reliance and offering safer, more accessible pain management solutions.
Currently, Journavx™ (Suzetrigine) is approved in the U.S. for the treatment of moderate to severe acute pain. However, there is no publicly available information regarding its approval status in Europe, and Vertex Pharmaceuticals has not yet announced any European regulatory plans.
What are your thoughts on the future of pain management? Share your views in the comments below!
References
This article was written by Neave Smith and edited by Rebecca Pope, with graphics produced by Suzana Sultan. If you enjoyed this article, be the first to be notified about new posts by signing up to become a WiNUK member (top right of this page)! Interested in writing for WiNUK yourself? Contact us through the blog page and the editors will be in touch.
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