Phase III follow up with HTX 011 shows effective pain management post-hernia operation-. Heron Therapeutics

Heron Therapeutics announced results of a multi-center postoperative pain management study in which 63 patients undergoing hernia repair surgery received the investigational agent, HTX 011 (bupivacaine + meloxicam extended release), together with a regimen of generic over-the-counter (OTC) oral analgesics (acetaminophen and ibuprofen). Designed as a follow-up to the Phase III study in hernia repair completed in 2018, this study included many of the same investigators and the same entry criteria as the Phase III study. The goal of the current study was to increase the proportion of opioid-free patients by combining HTX-011 with a regimen of readily available, oral analgesics.

Topline results of the study include the following: 90% of patients receiving HTX-011 with the OTC analgesic regimen did not require opioids to manage their postoperative pain through 72 hours post-surgery, compared to 51%, 40% and 22% of patients receiving HTX-011, bupivacaine and placebo, respectively, in the prior Phase III study. In addition 81% of patients receiving HTX-011 with the OTC analgesic regimen remained opioid-free through 28 days post-surgery. Over 72 hours post-surgery, patients receiving HTX-011 plus the OTC analgesic regimen consumed an average of 0.9 morphine milligram equivalents (MME), which compares to 10.8 MME, 14.5 MME and 17.5 MME for patients receiving HTX-011, bupivacaine and placebo, respectively, in the prior Phase III study.

Comment: Recently, a U.S. Food and Drug Administration Advisory Committee reported that, at time of discharge, patients receive an average of 30 opioid pills (range of 15-120 opioid pills) following open hernia repair surgery, while only 9 of these opioid pills are used. This suggests that, with a drug that substantially reduces the need for postoperative opioids such as HTX-011, surgeons could eliminate opioid prescriptions for almost all of their patients and in turn significantly reduce excess opioid pills going out into communities. For hernia repair alone, this would mean a reduction of almost 30 million opioid pills every year.