Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VX-548 · 10 trials · 3 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 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 |
|---|---|---|
| VX-548 | EXPERIMENTAL | Participants will receive VX-548 up to 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to VX-548 up to 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. |
| 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. |
| Part A | EXPERIMENTAL | Participants will receive a single dose of VX-548 on Day 1 and a single dose of omeprazole once daily (qd) on Days 10 through Day 12. On Day 13, participants will receive omeprazole followed by VX-548 under fasted conditions. |
| Part B | EXPERIMENTAL | Participants will receive a single dose of VX-548 on Day 1 followed by rifampin qd on Days 10 through Day 27. On Day 19, participants will be co-administered rifampin and VX-548 under fasted conditions. |
| 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 |
|---|---|---|
| VX-548 | DRUG | Tablets for oral administration. |
| Placebo | DRUG | Tablets for oral administration. |
| HB/APAP | DRUG | Capsules for oral administration. |
| Placebo (matched to VX-548) | DRUG | Placebo matched to VX-548 for oral administration. |
| Placebo (matched to HB/APAP) | DRUG | Placebo matched to HB/APAP 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) less than or equal to (\<=) 40 kg/ meter square (m\^2) * Diagnosis of PLSR for greater than (\>)3 months as per criteria pre-specified in the protocol * Weekly average of daily NPRS score \>...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
VX-548 is an investigational small molecule being developed for the treatment of pain, including acute pain and painful lumbosacral radiculopathy. It is being studied in clinical trials for these conditions. The drug is not approved and remains in clinical development.
VX-548 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical trials to evaluate the drug's efficacy and safety for pain-related conditions.
VX-548 is in Phase 2 clinical development. It has completed Phase 2 trials for acute pain and painful lumbosacral radiculopathy, as well as a Phase 1 trial. The drug is investigational and has not been approved by regulatory authorities.
VX-548 has completed several clinical trials, including NCT04977336 for acute pain after bunionectomy, NCT05034952 for acute pain after abdominoplasty, NCT05851157 for pain pharmacokinetics, and NCT06176196 for painful lumbosacral radiculopathy. All trials are completed with no active trials ongoing.
VX-548 is also known as suzetrigine. This alternative name is used in some contexts, and both names refer to the same investigational drug being developed by Vertex Pharmaceuticals for pain indications.