Table 3

Mean AUC of th NRS of pain intensity over time using wWOCF (ITT population)*

EndpointSaline placebo
(n = 100)
Bupivacaine HCl
50 mg
(n = 155)
HTX-011
60 mg/1.8 mg
(n = 157)
AUC0-8
 Mean (SD)37.55 (15.65)24.26 (14.23)20.68 (17.54)
 P value versus saline placebo<0.0001<0.0001
 P value versus bupivacaine HCl0.0477
AUC0-12
 Mean (SD)67.97 (22.98)50.37 (22.94)38.54 (28.08)
 P value versus saline placebo<0.0001<0.0001
 P value versus bupivacaine HCl<0.0001
AUC0-24
 Mean (SD)155.75 (48.49)131.36 (48.86)98.65 (59.55)
 P value versus saline placebo0.0004<0.0001
 P value versus bupivacaine HCl<0.0001
AUC24-7 2
 Mean (SD)289.59 (115.64)262.09 (117.25)224.64 (131.28)
 P value versus saline placebo0.0806<0.0001
 P value versus bupivacaine HCl0.0072
AUC0-72
 Mean (SD)445.34 (155.79)393.45 (153.76)323.29 (182.64)
 P value versus saline placebo0.0151<0.0001
 P value versus bupivacaine HCl0.0002
  • *ITT population includes all subjects who are randomized and received study drug. Analyzed using windowed worst observation carried forward (wWOCF). P values reflect results of an analysis of variance with randomized treatment as the main effect.

  • AUCx-y,area under the curve from x to y hours;HCl, hydrochloride;ITT, intent to treat;NRS, Numeric Rating Scale.