Efficacy results for the primary and key secondary endpoints (ITT population)*
| Endpoint | Saline placebo (n=100) | Bupivacaine HCl 50 mg (n=155) | HTX-011 60 mg/1.8 mg (n=157) |
| AUC0-72 of the NRS pain intensity scores† | |||
| Mean (SD) | 445.3 (155.8) | 393.5 (153.8) | 323.3 (182.6) |
| Primary endpoint: p value‡ versus saline placebo | <0.0001 | ||
| Secondary endpoint: p value‡ versus bupivacaine HCl | 0.0002 | ||
| Opioid consumption through 72 hours (MME) | |||
| Mean (SD) | 30.06 (21.01) | 25.09 (21.55) | 18.80 (19.80) |
| Median (min, max) | 25.0 (0, 80.0) | 17.5 (0, 92.5) | 12.5 (0, 83.0) |
| Secondary endpoint: p value§ versus saline placebo | <0.0001 | ||
| Secondary endpoint: p value§ versus bupivacaine HCl | 0.0022 | ||
| Opioid free through 72 hours | |||
| n (%) | 2 (2.0) | 17 (11.0) | 45 (28.7) |
| P value§ versus saline placebo | <0.0001 | ||
| Secondary end point: p value¶ versus bupivacaine HCl | 0.0001 |
Opioid free through 72 hours is defined as subjects who had total MME opioid dose=0 from 0–72 hours. All doses of opioid rescue medication are expressed as intravenous MME.
*ITT population includes all subjects who are randomized and receive study drug. This population was used as the primary analysis population for all efficacy endpoints.
†Analyzed using wWOCF.
‡P values reflect results of an analysis of variance with randomized treatment as the main effect.
§P values were obtained using the Wilcoxon rank-sum test.
¶P values from Fisher's exact test.
AUC0-72, area under the curve through 72 hours; HCl, hydrochloride; ITT, intent to treat; MME, morphine milligram equivalent; NRS, Numeric Rating Scale of the pain intensity score; wWOCF, windowed worst observation carried forward.