Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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
Also known as Suzetrigine (SUZ), SUZ, Journavx, VX-548
Suzetrigine · 20 trials · 5 indications
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the baseline pain intensity score from the pain intensity score at each postdose time point (using pain rating score range: 0 =no pain to 10 =worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPIDr0-48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
| Arm | Type | Description |
|---|---|---|
| Suzetrigine (SUZ) | EXPERIMENTAL | Participants will be randomized to receive SUZ. |
| Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to SUZ. |
| Pregabalin | ACTIVE_COMPARATOR | Participants will be randomized to receive Pregabalin. |
| Hydrocodone bitartrate/acetaminophen (HB/APAP) | ACTIVE_COMPARATOR | Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours. |
| VX-548 | EXPERIMENTAL | Participants will receive VX-548 up to 12 weeks. |
| Suzetrigine (SUZ): Low Dose | EXPERIMENTAL | Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks. |
| Suzetrigine (SUZ): Mid Dose | EXPERIMENTAL | Participants received SUZ 46 mg tablet qd for 12 weeks. |
| Suzetrigine (SUZ): High Dose | EXPERIMENTAL | Participants received SUZ 69 mg tablet qd for 12 weeks. |
| HB/APAP | ACTIVE_COMPARATOR | Participants received HB 5 mg / APAP 325 milligrams (mg) every 6 hours (q6h) for 2 days. |
| VX-548: Low Dose | EXPERIMENTAL | Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg every 12 hours (q12h) for 2 days. |
| VX-548: High Dose | EXPERIMENTAL | Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days. |
| VX-548: Mid Dose | EXPERIMENTAL | Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days. |
| SUZ and Efavirenz | EXPERIMENTAL | Participants will receive a single dose of SUZ on Days 1 through 15. Participants will also receive a single dose of SUZ in the morning followed by a single dose of efavirenz in the evening on Days 16 through 30. |
| SUZ | EXPERIMENTAL | Participants will receive a single dose of SUZ on Day 1. |
| Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE) | EXPERIMENTAL | Participants will receive a single dose of DRSP/EE on Days 1 and 20. Participants will also receive SUZ every 12 hours (q12h) from Days 7 through 25. |
| Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE) | EXPERIMENTAL | Participants will receive a single dose NGM/EE on Days 1 and 22. Participants will also receive SUZ every 12 hours (q12h) from Days 9 through 29. |
| Part A | EXPERIMENTAL | Participants will be randomized to receive a single dose of SUZ in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two tablet formulations and the effect of food on the PK of SUZ. There will be a 14-day washout period between each dosing period. |
| Part B | EXPERIMENTAL | Participants will be randomized to receive a single dose of SUZ formulation in 1 of 2 treatment sequences with 2 dosing periods to assess the relative bioavailability of tablet formulation compared to a suspension of SUZ. There will be a 14-day washout period between each dosing period. |
| Group 1 | EXPERIMENTAL | Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points. |
| Group 2A | ACTIVE_COMPARATOR | Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points. |
| Group 2B | ACTIVE_COMPARATOR | Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points. |
| Cohort 1: Severe Renal Impairment | EXPERIMENTAL | Participants will receive a single dose of VX-548 in a fasted state. |
| Cohort 2: Matched Healthy Participants | EXPERIMENTAL | Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state. |
| Cohort 3: Moderate Renal Impairment | EXPERIMENTAL | Participants will receive a single dose of VX-548 in a fasted state. |
| Cohort 4: Matched Healthy Participants | EXPERIMENTAL | Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state. |
| Cohort 1: Mild Hepatic Impairment | EXPERIMENTAL | Participants will receive multiple doses of VX-548 every 12 hours (q12h) from Day 1 through Day 14. |
| Cohort 3: Moderate Hepatic Impairment | EXPERIMENTAL | Participants will receive multiple doses of VX-548 q12h from Day 1 through Day 14. |
| Arm 1 | EXPERIMENTAL | Participants will receive a single dose of midazolam and digoxin on Day 1 in dosing period 1 followed by VX-548 every 12 hours (q12h) on Days 6 through 23 in dosing period 2. On Day 19, single doses of midazolam and digoxin will be administered with the morning dose of VX-548. |
| Sequence 1 | EXPERIMENTAL | Participants will receive VX-548 reference tablet (TF1) under fasted condition in dosing period 1, then VX-548 test tablet (TF2) under fasted condition in dosing period 2, and finally VX-548 test tablet (TF2) under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
| Sequence 2 | EXPERIMENTAL | Participants will receive VX-548 TF1 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
| Sequence 3 | EXPERIMENTAL | Participants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
| Sequence 4 | EXPERIMENTAL | Participants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
| Sequence 5 | EXPERIMENTAL | Participants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
| Sequence 6 | EXPERIMENTAL | Participants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF2 under fasted condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
| Name | Type | Description |
|---|---|---|
| Suzetrigine | DRUG | Tablets for oral administration |
| Placebo (matched to SUZ) | DRUG | Placebo matched to SUZ for oral administration. |
| Pregabalin | DRUG | Capsules for oral administration. |
| Placebo (matched to Pregabalin) | DRUG | Placebo matched to Pregabalin for oral administration. |
| Suzetrigine (SUZ) | DRUG | Tablets for oral administration. |
| HB/APAP | DRUG | Capsules for oral administration. |
| Placebo (matched to HB/APAP) | DRUG | Placebo matched to HB/APAP for oral administration. |
| VX-548 | DRUG | Tablets for oral administration. |
| Placebo | DRUG | Tablets for oral administration. |
| Placebo (matched to VX-548) | DRUG | Placebo matched to VX-548 for oral administration. |
| Efavirenz | DRUG | Tablet for oral administration. |
| DRSP/EE | DRUG | Combination Tablets for Oral Administration. |
| NGM/EE | DRUG | Combination Tablets for Oral Administration. |
| Moxifloxacin | DRUG | Capsules for oral administration. |
| Moxifloxacin Placebo | DRUG | Capsules for oral administration. |
| VX-548 Placebo | DRUG | Tablets for oral administration. |
| Omeprazole | DRUG | Tablets for oral administration. |
| Rifampin | DRUG | Capsules for oral administration. |
| Midazolam | DRUG | Syrup for oral administration. |
| Digoxin | DRUG | Tablets for oral administration. |
Key Inclusion Criteria: * Body weight greater than or equal to (≥)45 kilogram (kg) * Body mass index (BMI) ≥18 to less than (\<) 40 kilogram per meter square (kg/m\^2) * Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pa...
Suzetrigine is an investigational small molecule drug being developed for the treatment of pain. It is being studied in acute pain and in diabetic peripheral neuropathic pain, a type of nerve pain associated with diabetic peripheral neuropathy. It is a Phase 3 clinical development candidate and has not been approved by the FDA.
Suzetrigine is being evaluated for pain associated with diabetic peripheral neuropathy, a nerve pain condition linked to diabetes. A Phase 3 trial, NCT07231419, is studying its efficacy and safety in adults with diabetic peripheral neuropathic pain. Suzetrigine is investigational and is not approved for this or any other use.
Suzetrigine is being developed by Vertex Pharmaceuticals Incorporated, which trades on the Nasdaq under the ticker VRTX. Vertex is the sponsor of the clinical program, which includes Phase 1 pharmacokinetic studies and a Phase 3 trial in diabetic peripheral neuropathic pain.
Suzetrigine is in Phase 3 clinical development. Its program includes a recruiting Phase 3 trial in diabetic peripheral neuropathic pain, NCT07231419, along with completed Phase 1 studies. Suzetrigine is investigational and has not been approved by the FDA.
Suzetrigine has been studied across five clinical trials. The Phase 3 trial NCT07231419 is recruiting adults with diabetic peripheral neuropathic pain. Completed Phase 1 studies include NCT07570069, which examined efavirenz effects on suzetrigine pharmacokinetics, NCT07378865 on excretion into breast milk, and NCT06820307 on oral contraceptive pharmacokinetics.
Yes, SUZ is an abbreviation used for suzetrigine. The Phase 3 trial in diabetic peripheral neuropathic pain, NCT07231419, and the Phase 1 oral contraceptive pharmacokinetic study, NCT06820307, both refer to the drug as suzetrigine (SUZ). Searches for either name refer to the same investigational pain candidate from Vertex Pharmaceuticals.