Journavx: A Newly-Approved, Non-Opioid Pain Medication

Background

The search for a solution to treat pain has led to the development of several pain medications over the years, some with dangerous effects. An example of this is OxyContin, a dangerous, potent opioid pain medication that largely contributed to the opioid epidemic. According to the CDC, in 2022 alone there were 82,000 opioid overdose deaths in the U.S., of which 15,000 involved prescription opioids¹.

To avoid the detrimental effects that stem from the over-prescribing and over-use of opioid-pain relievers, clinicians have sought alternatives for pain management.  Recently, there has been a turning point in this ongoing effort with the FDA approval of a new, non-opioid pain medication, Journavx². According to the FDA, the medication, developed by Vertex Pharmaceuticals, is the first in a new class of pain medications³. So far, studies measuring the efficacy and safety have shown positive results¹. The approval of this medication is a crucial first step in shifting away from the use of opioid medications for treating pain.

Mechanism

The active ingredient in Journavx is suzetrigine, a sodium channel blocker². The mechanism in which Journavx works in the body differs from that of other typical opioid pain medications. Its effects take place outside the brain and spinal cord, solely affecting the peripheral nervous system². According to Vertex Pharmaceuticals, Journavx works by targeting a specific sodium channel in the peripheral nervous system. The pain-relieving effects of the medication come from the inhibition of the NaV1.8 channel, which blocks pain signals before they reach the spinal cord. Due to this mechanism, Journavx is claimed to be non-addictive, as the drug does not enter the brain². 

Effects

Prior to Journavx’s approval, two phase 3 randomized, double-blind, placebo-controlled trials were conducted³. The eligibility criteria for these trials included having moderate to severe pain rated on the verbal pain rating scale (VRS), a pain rating of 4 or greater on the numeric pain rating scale (NRS) and included individuals having undergone a bunionectomy or abdominoplasty procedure previously within a specified time frame⁴. The goal of these studies was to measure the time-weighted pain within 48 hours in the suzetrigine (Journavx) group compared to the placebo group and a group receiving hydrocodone⁴. Results of the trials showed a significant reduction in pain among the groups receiving suzetrigine compared to the placebo groupl⁴. Compared to the group receiving hydrocodone, suzetrigine was found to provide pain relief similar to, but not superior to, hydrocodone in either trial⁴.

Journavx is a non-NSAID, meaning it does not carry risk of kidney or gastrointestinal damage with long-term use, as seen with NSAIDS¹. There is a need for further research examining the effectiveness of Journavx compared to NSAID medications for pain management.

According to the manufacturer, Journavx is offered in doses of 50mg tablets³. As per manufacturer instructions, the initial dose is 100mg taken orally on an empty stomach, followed by 50mg every 12 hours⁴. Some of the most common side effects reported by patients include pruritus, increased creatine phosphokinase levels, skin rash, and muscle spasms⁴. Long-term use is not recommended, as effects have not been studied over 14 days⁴.

Implications

This novel opioid-free pain medication offers a safer alternative for managing pain, researchers have noted barriers to widespread utilization of this medication. Journavx is currently only approved for use in treating acute pain². The results of the clinical trials conducted so far focused on its effectiveness in treating short-term or acute pain, often as seen following a surgery or accident⁵. However, Vertex has reported positive results of its use in treating chronic pain in patients with diabetic peripheral neuropathy².  The manufacturer has also announced that a phase 3 clinical trial is in progress, hopefully making the drug a suitable option in the future for individuals experiencing chronic and/or moderate pain⁴.

According to providers from several U.S. states, they anticipate the biggest hurdle to prescribing Journavx will be the cost⁵. A common issue experienced by patients is insurers refusing to cover newer, more costly treatments⁵. The manufacturer set the price of the drug at $31 per day, or $15.50 per tablet⁵. Although Journavx is comparatively much safer than opioid pain medications, the per-day cost is several times higher than medications like hydrocodone that cost less than $5 per tablet⁵.

The FDA’s Overdose and Prevention Framework has long supported the development of non-opioid alternatives for pain and offers incentives for the development of non-opioid analgesics². Two congressional acts recently enacted, the Alternatives to Prevent Addiction in the Nation Act and Non-Opioids Prevent Addiction in the Nation Act (NOPAIN Act), aim to amend Medicare and increase accessibility and affordability of non-opioid pain medications, including Journavx⁶. Despite concerns of its adoption, the development of this medication is an important milestone. Vertex’s new medication paves the way for a new, safer way to treat pain, and the development of more medications of its kind in the future.

Conclusion

MATTERS does not endorse any specific medications, including Journavx. This article is intended to be used for educational purposes only. To access articles and other educational materials, visit the MATTERS website at https://mattersnetwork.org/edu/.

References

1. FDA approval of Vertex’s non-opioid JOURNAVX signals new era in pain treatment. BioSpace. February 7, 2025. Accessed February 17, 2025. https://www.biospace.com/drug-development/fda-approval-of-vertexs-non-opioid-journavx-signals-new-era-in-pain-treatment.
2. Vertex announces FDA approval of JOURNAVXTM (Suzetrigine), a first-in-class treatment for adults with moderate-to-severe acute pain. Business Wire. January 30, 2025. Accessed February 24, 2025. https://www.businesswire.com/news/home/20250109747971/en/.
3. Commissioner O of the. FDA approves novel non-opioid treatment for moderate to severe acute pain. U.S. Food and Drug Administration. Accessed February 17, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain.
4. JOURNAVX, a nonopioid oral pain medication, gets FDA approval. Rheumatology Advisor. February 4, 2025. Accessed February 18, 2025. https://www.rheumatologyadvisor.com/news/journavx-a-nonopioid-oral-pain-medication-gets-fda-approval/.
5. Bell J. A new, non-opioid pain drug is here. getting it to patients could be agony. BioPharma Dive. January 31, 2025. Accessed February 18, 2025. https://www.biopharmadive.com/news/pain-drug-vertex-opioid-price-insurance-journavx/738856/.