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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05553366 | Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy | PHASE3 | COMPLETED | 1,075 | — | — | Oct 3, 2022 | Dec 15, 2023 | Aug 1, 2025 | 21 | 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 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).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to suzetrigine (SUZ) and hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days. |
| Hydrocodone bitartrate/acetaminophen (HB/APAP) | ACTIVE_COMPARATOR | Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days. |
| Suzetrigine (SUZ) | EXPERIMENTAL | Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 2 days. |
| Name | Type | Description |
|---|---|---|
| SUZ | DRUG | Tablets for oral administration. |
| HB/APAP | DRUG | Capsules for oral administration. |
| Placebo (matched to SUZ) | DRUG | Placebo matched to SUZ for oral administration. |
| Placebo (matched to HB/APAP) | DRUG | Placebo matched to HB/APAP for oral administration. |
Key Inclusion Criteria: * Before Surgery * Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block) * After Surgery * Participant is lu...
| 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 |