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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03764072 | A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy | PHASE2 | COMPLETED | 250 | — | — | Dec 12, 2018 | Jan 25, 2019 | Feb 9, 2022 | 6 | United States |
| NCT03206749 | A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy | PHASE2 | COMPLETED | 243 | — | — | Jun 29, 2017 | Dec 8, 2017 | Feb 3, 2021 | 4 | 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). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (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). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to VX-150 for 2 days. |
| VX-150 - Dose Level 1 | EXPERIMENTAL | Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days. |
| VX-150 - Dose Level 2 | EXPERIMENTAL | Participants received VX-150 1000 mg once daily (qd) for 2 days. |
| VX-150 - Dose Level 3 | EXPERIMENTAL | Participants received VX-150 500 mg q12h for 2 days. |
| VX-150 - Dose Level 4 | EXPERIMENTAL | Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days. |
| VX-150 - Dose Level 5 | EXPERIMENTAL | Participants received VX-150 250 mg qd for 2 days. |
| VX-150 | EXPERIMENTAL | - |
| Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| VX-150 | DRUG | Capsules for oral administration. |
| Placebo | DRUG | Capsules for oral administration. |
| HB/APAP | DRUG | Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days. |
Key Inclusion Criteria: Before surgery: * Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m\^2) * Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not t...
| 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 |