Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures

University of California Irvine (UCI)

Status and phase: Invitation-only; Phase 4

Conditions: Rib Fractures

Treatments: Drug: Placebo; Drug: Suzetrigine (SUZ)

Study type: Interventional

Funder types: Other

Identifiers

NCT07145346

7663

Details and patient eligibility

About

Rib fractures cause a significant amount of pain and are associated with an increased risk of lung infections, long hospitalization, and increased cost. Effective pain control is the cornerstone of management to improve lung function and minimize complications. Most often this is done with a multimodal pain routine consisting of: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), topical lidocaine, muscle relaxants, and opioids. However, suzetrigine is a promising alternative to treat acute pain associated with rib fractures. We think the addition of suzetrigine to a multimodal pain regimen will improve pain and decrease opioid use.

Full description

Rib fractures are a common and painful injury associated with increased risk of pneumonia, prolonged hospitalization, and higher healthcare utilization. In a national database review, rib fractures were associated with a 10% mortality rate, with mortality increasing incrementally with each additional rib fractured. Effective analgesia is essential in management of these injuries, as improved pain control optimizes pulmonary mechanics and reduces complications. Current analgesic strategies include multimodal pain regimens consisting of oral and transdermal analgesics or regional anesthetics such as epidural catheters. Historically, opioids have been a major component of analgesia, however they are highly addictive and can lead to respiratory depression and epidurals are invasive procedures with associated risks.

Suzetrigine (Journavx) is a newly United States Food and Drug Administration (FDA)-approved, oral non-opioid analgesic that selectively inhibits the NaV1.8 voltage-gated sodium channel, which is solely expressed in peripheral nociceptive neurons. A systematic review including multiple phase III trials demonstrated suzetrigine's efficacy for pain management in both non-surgical and post-surgical patients. Suzetrigine has also been shown to have comparable analgesia to oral opioids with fewer side effects, such as nausea, vomiting, and need for rescue pain medication.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 18 years old
• Blunt trauma patients
• > 3 rib fractures
• Able to tolerate oral intake

Exclusion criteria

• < 17 years old

• Pregnant

• Prisoners

• History of adverse reaction to suzetrigine

• Current strong CYP3A inhibitor medication use

  o Strong Inhibitors: clarithromycin, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, atazanavir, darunavir, indinavir, lopinavir, telithromycin

• Current strong or moderate CYP3A inducer

  • Strong Inducers: apalutamide, carbamazepine, encorafenib, enzalutamide, fosphenytoin, lumacaftor and ivacaftor, mitotane, phenytoin, rifampin
  • Moderate Inducers: bexarotene (Systemic), bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, estradiol, and norethindrone, eslicarbazepine, etravirine, fexinidazole, lorlatinib, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, phenobarbital, primidone, repotrectinib, rifabutin, rifapentine, sotorasib, St John's Wort

• Cirrhosis

• GCS < 14

• Rhabdomyolysis (CPK > 5,000 U/L)

• Chronic opioid use (>30mg OME/day)

• Known or suspected active infection with human immunodeficiency virus or hepatitis B or C viruses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups, including a placebo group

Suzetrigine arm

Experimental group

Description:

The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).

Treatment:

Drug: Suzetrigine (SUZ)

Control arm

Placebo Comparator group

Description:

The control arm will receive placebo capsules matched to suzetrigine for oral administration.

Treatment:

Drug: Placebo