ABCDE
1Main
2BrandVX-548
3Generic
4IndicationPain
5MOANav1.8
6DosingLoading dose with q12h thereafter
7Clinical Trials
8Phase III bunionectomy or abdominoplasty n=2000
9
10
11
12Phase II n=274 dose-ranging bunionectomy
13SPID48 change from baseline
14Placebo101
15100mg first dose/50mg q12h137.8p=0.0251
1660mg first dose/30mg q12h86.9p=NS
1720mg first dose/10mg q12h112.9p=NS
18hydrocodone115.6p=NS
19
20
21Phase II n=303 dose-ranging abdominoplasty
22SPID48 change from baseline
23Placebo72.7
24100mg first dose/50mg q12h110.5p=0.0097
2560mg first dose/30mg q12h95.1p=NS
26hydrocodone85.2p=NS