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Main | | | | |
| Brand | VX-548 | | |
| Generic | | | |
| Indication | Pain | | |
| MOA | Nav1.8 | | |
| Dosing | Loading dose with q12h thereafter | | |
| Clinical Trials | | | |
| | Phase III bunionectomy or abdominoplasty n=2000 | | |
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| | Phase II n=274 dose-ranging bunionectomy | | |
| | | SPID48 change from baseline | |
| | Placebo | 101 | |
| | 100mg first dose/50mg q12h | 137.8 | p=0.0251 |
| | 60mg first dose/30mg q12h | 86.9 | p=NS |
| | 20mg first dose/10mg q12h | 112.9 | p=NS |
| | hydrocodone | 115.6 | p=NS |
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| | Phase II n=303 dose-ranging abdominoplasty | | |
| | | SPID48 change from baseline | |
| | Placebo | 72.7 | |
| | 100mg first dose/50mg q12h | 110.5 | p=0.0097 |
| | 60mg first dose/30mg q12h | 95.1 | p=NS |
| | hydrocodone | 85.2 | p=NS |