Effective Date

Date of Origin 

10-01-2025            

10-01-2025

Journavx™ 

(suzetrigine)

Tablet

Indicated for the treatment of moderate to severe acute pain in adults

1

Clinical Rationale

The Centers for Disease Control and Prevention (CDC) guidelines define acute pain as pain with abrupt onset and caused by an injury or other process that is not ongoing.(2) A retrospective cross-sectional study using two nationally representative datasets from 2019 estimated that 80.2 million patients in the US annually experience pain requiring prescription medication treatment for less than three months.(4) Long-term opioid use often begins with treatment of acute pain.(2) The opioid epidemic has heightened prescriber and community awareness of the harms of opioid medications.(3) Opioids can have significant adverse effects including sedation, respiratory depression, confusion, falls, and constipation. However, a significant concern with use of these agents for acute pain is the risk of developing persistent opioid use and/or opioid use disorder (OUD).(4) A report generated by the US Health and Human Services Pain Management Best Practices Inter-Agency Task Force emphasizes the need for individualized, multimodal, and multidisciplinary approaches to pain management that decreases the over-reliance on opioids, increases access to care, and promotes widespread education on pain and substance use disorders. The goal of treating acute pain is to relieve suffering, facilitate function and minimize adverse effects.(5)

Efficacy

The efficacy of suzetrigine in the treatment of moderate to severe acute pain in adults was established in two randomized, double-blinded, placebo and active-controlled trials of acute pain, one following full abdominoplasty (Trial 1) and the other following bunionectomy (Trial 2). Eligible patients had moderate to severe pain on the verbal categorical rating system (VRS) and a pain score of four or higher on the numeric pain rating scale (NPRS) within four hours of the abdominoplasty completion or during the 9-hour period after discontinuation of regional anesthesia following bunionectomy. Patients were randomized to receive oral suzetrigine, placebo or hydrocodone bitartrate/acetaminophen (HB/APAP) for a duration of 48 hours. Patients in the suzetrigine treatment arm received an initial loading dose of suzetrigine 100 mg, followed by 50 mg every 12 hours. Patients in the HB/APAP-control arm received 5 mg/325 mg every six hours. In both studies, 400 mg of ibuprofen every 6 hours, as needed for pain relief, was permitted as a rescue medication. Efficacy was evaluated by the time-weighted sum of the pain intensity diference from 0 to 48 hours (SPID48) compared to the placebo group and then to the HB/APAP group. Treatment with suzetrigine demonstrated statistically significant reduction in pain compared to treatment with placebo in both trials. Pain reduction was comparable between suzetrigine and HB/APAP. Suzetrigine had a faster median time to meaningful pain relief (defined as a 2 or more point reduction in NPRS) than placebo in both trials.(1)

Of note, use of suzetrigine for the treatment of moderate to severe acute pain has not been studied beyond 14 days.(1)

Safety

Suzetrigine is contraindicated when used concomitantly with strong CYP3A inhibitors.(1)

1

Journavx prescribing information. Vertex Pharmaceuticals. January 2025.

2

Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. MMWR Recomm Rep 2022;71(No. RR-3):1–95. DOI: http://dx.doi.org/10.15585/mmwr.rr7103a1.

3

Amaechi O, Huffman MM, Featherstone K. Pharmacologic Therapy for Acute Pain. Am Fam Physician. 2021 Jul 1;104(1):63-72. PMID: 34264611.

4

Rind DM, McQueen B, Nikitin D, Lee W, DiStefano MJ, Raymond F, Zemplenyi A, Ollendorf D. Suzetrigine for Acute Pain; Evidence Report. Institute for Clinical and Economic Review, February 5, 2025 https://icer.org/assessment/acute-pain-2025.

5

Mariano, E. R., Dickerson, D. M., Szokol, J. W., Harned, M., Mueller, J. T., Philip, B. K., Baratta, J. L., Gulur, P., Robles, J., Schroeder, K. M., Wyatt, K. E., Schwalb, J. M., Schwenk, E. S., Wardhan, R., Kim, T. S., Higdon, K. K., Krishnan, D. G., Shilling, A. M., Schwartz, G., … Buvanendran, A. (2021). A multisociety organizational consensus process to define guiding principles for acute perioperative pain management. Regional Anesthesia & Pain Medicine, 47(2), 118–127. https://doi.org/10.1136/rapm-2021-103083.

Journavx

suzetrigine tab

50 MG

29

Tablets

90

DAYS

Journavx

suzetrigine tab

50 MG

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QL

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met: 

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. The requested quantity (dose) exceeds the program quantity limit AND BOTH of the following:
   1. The requested agent is being used for the treatment of acute pain AND
   2. ONE of the following:
      1. BOTH of the following:
         1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
         2. There is support for therapy with a higher dose for the requested indication OR
      2. BOTH of the following:
         1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
         2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
      3. BOTH of the following:
         1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
         2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 3 months