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Heron Therapeutics Announces Publication of Results from EPOCH 2, a Phase 3 Study of HTX-011 in Patients Undergoing Hernia Repair Surgery
SAN DIEGO, Aug. 20, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"SAN DIEGO, Aug. 20, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the results from EPOCH 2, a Phase 3 study of the investigational agent HTX-011 in open inguinal hernia repair surgery with mesh, have been published in the journal, Hernia, in an article entitled \"HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study.\" HTX-011 achieved all primary and key secondary endpoints in EPOCH 2, 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. \nHTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. Heron has completed two pivotal Phase 3 studies of HTX-011: EPOCH 1 in bunionectomy, which is a study of a bony tissue surgical model, and EPOCH 2 in hernia repair, which is a study of a soft tissue surgical model.\nIn EPOCH 2, 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. HTX-01...