On January 30, 2025, the U.S. Food and Drug Administration approved JOURNAVX (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic for the treatment of moderate to severe acute pain in adults.
JOURNAVX (suzetrigine), which is an oral sodium channel blocker manufactured by Vertex Pharmaceuticals, represents a breakthrough in pain management as the first drug in a new class of non-opioid pain medicines. According to the FDA, JOURNAVX works by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. This novel mechanism of action differs significantly from both opioid and non-steroidal anti-inflammatory drugs (NSAIDs) commonly used in workers’ compensation cases, serving as a non-addictive option for pain management.
The FDA granted JOURNAVX Breakthrough Therapy, Fast Track, and Priority Review designations, highlighting its potential significance in addressing unmet needs in pain management. Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, described the approval as “an important public health milestone in acute pain management” that offers “an opportunity to mitigate certain risks associated with using an opioid for pain.”
Clinical Evidence and Safety Profile
The FDA’s approval of JOURNAVX was based on two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain following abdominoplasty and bunionectomy. Both trials demonstrated a statistically significant superior reduction in pain with JOURNAVX compared to placebo. Participants with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication.
The safety profile was established from pooled data involving 874 participants with moderate to severe acute pain, with additional supportive safety data from a single-arm, open-label study in 256 participants with a range of acute pain conditions. The most common adverse reactions reported included:
- Itching
- Muscle spasms
- Increased blood level of creatine phosphokinase
- Rash
Importantly, JOURNAVX is contraindicated for concomitant use with strong CYP3A inhibitors. Injured employees should also avoid food or drink containing grapefruit when taking this medication.
Implications for Workers’ Compensation
The approval of JOURNAVX has several potential implications for workers’ compensation programs. This medication represents one of the promising non-opioid alternatives that we previously highlighted in our February 22, 2024 article “The Quest for New Pain Medications: Developments in Non-Opioid Painkillers Offer Hope for Pain Relief without Addiction.”
- Alternative to Opioids
As a non-opioid option for moderate to severe acute pain, JOURNAVX may provide prescribers with an alternative to opioid medications in appropriate cases. This aligns with ongoing efforts to reduce reliance on opioids in workers’ compensation.
- Specific Applications in Work Injuries
Based on the clinical trials, JOURNAVX may be particularly relevant for post-surgical pain management following procedures commonly associated with workplace injuries. The studies specifically evaluated pain control after abdominoplasty and bunionectomy, suggesting efficacy in post-surgical settings.
- Drug Interactions and Safety Considerations
The contraindication with strong CYP3A inhibitors and the grapefruit warning are important considerations for medication therapy management, especially in cases where injured workers may be taking multiple medications.
- Limited Duration of Use
The FDA approval specifies that JOURNAVX should be used for the treatment of acute pain for the shortest duration consistent with treatment goals. This time-limited application may influence its role in workers’ compensation cases, where acute pain management is often needed during the initial recovery period following workplace injuries. Clinical trials are currently underway to test JOURNAVX for the treatment of chronic pain.
- Pricing
As is typical with brand name medications at launch, JOURNAVX comes with a substantial price point. The average wholesale price (AWP) per JOURNAVX tablet is $18.60. According to Vertex Pharmaceuticals, the recommended dosage for adult patients with moderate-to-severe pain is a loading dose of two 50 mg tablets followed by one 50 mg tablet every 12 hours beginning 12 hours after the loading dose. The AWP value (prior to PBM discounts) for this 14-day dosing is $558. While the upfront cost is significant, payers must weigh this against the potential economic and clinical benefits of avoiding opioid dependence, addition-related treatment costs, and the potential for improved patient outcomes over the long term.
Clinical Perspective
“As with any new medication, we’ll be closely monitoring real-world outcomes as JOURNAVX enters clinical practice,” said Jim Andrews, RPh, chief clinical officer of Preferred Medical Solutions. “The 14-day duration limitation aligns well with best practices for acute pain management and should help contain costs while addressing a critical need in the immediate post-injury period.”
Additional considerations include:
- The interaction of JOURNAVX with common comorbidities seen in workers’ compensation patients has yet to be fully evaluated in real-world settings
- Potential interactions with other medications that injured workers may be taking require careful assessment
- Additional side effects may emerge as the medication is used more widely across diverse patient populations
- The limitation to acute pain for two weeks or less may help contain claim costs while addressing a critical need in the immediate post-injury period
While JOURNAVX represents a potentially valuable addition to the treatment options available for injured workers, responsible management of new medications requires careful consideration of clinical appropriateness, cost factors, and outcomes monitoring.
For more information on how our pharmacy benefit management programs help optimize medication therapy while controlling costs, please contact us. Read more about emerging non-opioid painkillers.