Phase III EPOCH 1 study of HTX 011 in bunionectomy published in Regional Anesthesia & Pain Medicine

Heron Therapeutics announced that the results from the pivotal Phase III EPOCH 1 bunionectomy study of the investigational agent HTX 011 (bupivacaine + meloxicam extended release) have been published online by the Regional Anesthesia & Pain Medicine (RAPM) journal. The article, entitled "HTX 011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study," also will be published in the July 2019 print issue of RAPM. HTX-011 achieved all primary and key secondary endpoints in the EPOCH 1 study, demonstrating statistically significant reductions in both pain intensity and the use of opioid rescue medications following surgery and an increase in the proportion of patients who were opioid-free.

In the EPOCH 1 study, all primary and key secondary endpoints were achieved. HTX-011 provided superior and sustained pain reduction compared to placebo and bupivacaine solution through the critical 72-hour postoperative window, when pain is often most severe. Significant reductions in pain occurred both early (in the first 8 through 24 hours) and were sustained from 24 through 72 hours. In addition to reductions in average pain intensity scores, HTX-011 significantly reduced the proportion of patients experiencing severe pain through 72 hours compared to placebo and bupivacaine solution. Significant reductions in pain were consistent with the significant decrease in total opioid consumption and the significant increase in opioid-free patients receiving HTX-011, both through 72 hours and as compared to placebo and bupivacaine solution. Most patients that required no opioids in the first 72 hours after surgery (82%) continued to be opioid-free through 28 days. HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.

See: "HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study" Eugene Viscusi et al. Regional Anesthesia & Pain Medicine (RAPM) journal May 17 2019 doi: 10.1136/rapm-2019-100531