Approval Probability
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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
Also known as VX-548, Suzetrigine, JOURNAVX
SUZ · 22 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).
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 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. |
| SUZ | DRUG | Tablets 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...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
SUZ, also known as suzetrigine, is an investigational small molecule being developed for the treatment of acute pain and pain. It is currently in Phase 3 clinical development for acute pain, with a completed Phase 3 trial evaluating its efficacy and safety after a bunionectomy.
SUZ is a small molecule that targets pain pathways. As a selective NaV1.8 inhibitor, it works by blocking the NaV1.8 sodium channel, which plays a key role in pain signaling. This mechanism is being studied for its potential to provide pain relief without the risks associated with opioids.
SUZ is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. Vertex is conducting clinical trials to evaluate the safety and efficacy of SUZ for pain indications.
SUZ is in Phase 3 clinical development for acute pain. A Phase 3 trial (NCT05553366) has been completed, and a Phase 1 study (NCT06834009) has also been completed. SUZ is investigational and not yet approved by regulatory authorities.
SUZ has been studied in two completed clinical trials. The Phase 3 trial NCT05553366 evaluated the efficacy and safety of VX-548 for acute pain after a bunionectomy in 1075 participants. The Phase 1 trial NCT06834009 studied suzetrigine spray-dried dispersion in healthy adult panelists.
Yes, SUZ is also known as suzetrigine and was previously referred to as VX-548 in clinical trials. The Phase 3 trial NCT05553366 used the name VX-548, while the Phase 1 trial used the name suzetrigine (SUZ). Both names refer to the same investigational drug.