Journavx FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 31, 2025.
FDA Approved: Yes (First approved January 30, 2025)
Brand name: Journavx
Generic name: suzetrigine
Dosage form: Tablets
Previous Name: VX-548
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Pain
Journavx (suzetrigine) is a sodium channel blocker indicated for the treatment of moderate to severe acute pain in adults.
- Acute pain is a serious and potentially disabling condition often caused by surgery, accident or injury. Acute pain is often treated with opioids, but this can lead to prolonged opioid use, and many patients will go on to develop opioid use disorder.
- Journavx is a non-opioid, highly selective inhibitor of NaV1.8 voltage-gated sodium channels. NaV1.8 is expressed in peripheral sensory neurons including dorsal root ganglion neurons, where its role is to transmit pain signals. Journavx works to treat pain by inhibiting the transmission of pain signals to the spinal cord and brain.
- FDA approval of Journavx was supported by data from two randomized, double-blind, placebo and active-controlled trials of acute pain: Trial 1 (following full abdominoplasty) and Trial 2 (following bunionectomy). In each trial, pain intensity was measured using a patient-reported 11-point numeric pain rating scale (NPRS), ranging from 0 to 10, where zero corresponds to no pain and 10 corresponds to the worst pain imaginable. Patients were randomized to receive Journavx (100 mg loading dose followed by 50 mg every 12 hours), placebo, or hydrocodone bitartrate/acetaminophen (5 mg/325 mg every 6 hours). For both studies, ibuprofen (400 mg every 6 hours) was permitted as needed as a rescue medication.
- In Trial 1, treatment with Journavx demonstrated statistically significant superior reduction in pain compared to treatment with placebo. The median time to meaningful pain relief (defined as a ≥ 2-point reduction in NPRS) was 119 minutes for patients in the Journavx group and 480 minutes for patients in the placebo group. The median time to onset of perceptible pain relief (defined as a ≥ 1-point reduction in NPRS) for patients in the Journavx group was 34 minutes.
- In Trial 2, treatment with Journavx demonstrated statistically significant superior reduction in pain compared to treatment with placebo. The median time to meaningful pain relief was 240 minutes for patients in the Journavx group and 480 minutes in the placebo group. The median time to onset of perceptible pain relief for patients in the Journavx group was 60 minutes. - Journavx tablets are administered orally every 12 hours after an initial loading dose. Patients should avoid food or drink containing grapefruit when taking Journavx.
- Warnings and precautions associated with Journavx include an increased risk of adverse reactions in people with impaired liver function. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors.
- Common adverse reactions include pruritis, muscle spasms, rash, and increased creatine phosphokinase.
Development timeline for Journavx
Further information
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