Select efficacy results from HTX-011 phase III studies, EPOCH-1 (bunionectomy) and EPOCH-2 (herniorrhaphy)3–5
| EPOCH-1 | EPOCH-2 | |||||
| Saline placebo (n=100) | Bupivacaine HCl 50 mg (n=155) | HTX-011 60 mg/1.8 mg (n=157) | Saline placebo (n=82) | Bupivacaine HCl 75 mg (n=172) | HTX-011 300 mg/9 mg (n=164) | |
| Pain intensity | ||||||
| AUC0-24 of the NRS pain intensity scores | ||||||
| Mean (SD) | 155.8 (48.49) | 131.4 (48.86) | 98.7 (59.55) | 143.8 (54.94) | 126.7 (52.68) | 97.7 (60.31) |
| P value vs saline placebo | 0.0004 | <0.0001 | 0.0238 | <0.0001 | ||
| P value vs bupivacaine HCl | <0.0001 | <0.0001 | ||||
| AUC24-72 of the NRS pain intensity scores | ||||||
| Mean (SD) | 289.6 (115.64) | 262.1 (117.25) | 224.6 (131.28) | 207.1 (122.32) | 215.2 (111.97) | 171.7 (120.40) |
| P value vs saline placebo | 0.0806 | <0.0001 | 0.6041 | 0.0264 | ||
| P value vs bupivacaine HCl | 0.0072 | 0.0007 | ||||
| Opioid use | ||||||
| Opioid consumption from 0 to 24 hours (MME) | ||||||
| Mean (SD) | 14.1 (8.58) | 11.8 (9.39) | 7.4 (7.82) | 11.7 (10.82) | 7.3 (8.61) | 5.2 (7.86) |
| Median (min, max) | 14.0 (0.0 to 45.0) | 10.0 (0.0 to 44.0) | 5.0 (0.0 to 29.0) | 9.8 (0.0 to 37.0) | 5.0 (0.0 to 37.0) | 0.0 (0.0 to 35.0) |
| P value vs saline placebo | <0.0001 | <0.0001 | ||||
| P value vs bupivacaine HCl | <0.0001 | 0.0073 | ||||
| Opioid consumption from 24 to 72 hours (MME) | ||||||
| Mean (SD) | 15.9 (14.77) | 13.3 (14.56) | 11.4 (13.64) | 5.9 (9.30) | 7.2 (11.10) | 5.62 (11.09) |
| Median (min, max) | 12.5 (0.0 to 60.0) | 8.0 (0.0 to 57.0) | 5.0 (0.0 to 54.0) | 0.0 (0.0 to 37.0) | 0.0 (0.0 to 69.0) | 0.0 (0.0 to 68.0) |
| P value vs saline placebo | 0.0024 | 0.2532 | ||||
| P value vs bupivacaine HCl | 0.1585 | 0.0161 | ||||
| Opioid-free | ||||||
| % patients opioid-free through 72 hours | 2% | 11% | 29% | 22% | 40% | 51% |
| P value vs saline placebo | <0.0001 | <0.0001 | ||||
| P value vs bupivacaine HCl | 0.0001 | 0.0486 | ||||
AUC, area under the concentration time curve; MME, morphine milligram equivalents; NRS, numeric rating scale.