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Label indication JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. JOURNAVX is a sodium channel blocker indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. ( 1 ) FDA label
suzetrigine · 1 trial · 2 indications
Numerical Pain Rating Scale (NPRS) will be assessed during Cold Pressor Tests at various time points for time to reach Pain Detection Threshold (PDT) and time to reach Pain Tolerance Threshold (PTT)
Stopwatches will be used during each cold pressor test to determine time for subject to reach PDT and PTT
| Arm | Type | Description |
|---|---|---|
| Schedule A | OTHER | participants receive suzetrigine 100mg in treatment period 1, and receive placebo in treatment period 2 |
| Schedule B | OTHER | participants receive placebo in treatment period 1, and receive suzetrigine 100mg in treatment period 2 |
| Name | Type | Description |
|---|---|---|
| suzetrigine 100mg | DRUG | Suzetrigine is an inhibitor of the NaV1.8 voltage-gated sodium channel and FDA approved for the treatment of moderate-to-severe acute pain in adults |
| Placebo | OTHER | biologically inactive placebo comparator |
Inclusion Criteria: 1. Male participants aged 18 to 55 years, inclusive, at the time of signing the informed consent. 2. Overtly healthy with no clinically relevant abnormalities based on the medical history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that, in the opini...