Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05034952 | A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty | PHASE2 | COMPLETED | 303 | — | — | Aug 30, 2021 | Dec 21, 2021 | Dec 27, 2024 | 7 | United States |
| NCT04977336 | A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy | PHASE2 | COMPLETED | 274 | — | — | Jul 19, 2021 | Mar 4, 2022 | Jun 25, 2025 | 12 | United States |
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 |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to VX-548 and Hydrocodone bitartrate/ acetaminophen (HB/APAP) for 2 days. |
| 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. |
| Name | Type | Description |
|---|---|---|
| VX-548 | 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. |
Key Inclusion Criteria: * Before Surgery: * Participant scheduled to undergo an abdominoplasty without collateral procedures * After Surgery: * Participant is lucid and able to follow commands * All analgesic guidelines were followed during and after the abdominoplasty * Abdominoplasty pr...
| 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 | NA | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | — | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | — | Flozin |