Benzinga | Jan 21, 2021 08:39AM EST

Heron Therapeutics Highlights Publication Of Results From EPOCH 1 Follow-On Study Of HTX-001 In Patients With Undergoing Bunionectomy Surgery: '77% of Bunionectomy Patients Receiving HTX-011 Required No Opioids...'

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 an EPOCH 1 follow-on study (NCT03718039) of the investigational agent HTX-011 in bunionectomy, have been published online, by the Journal of the American Podiatric Medical Association in an article entitled "Opioid-Free Recovery from Bunionectomy with HTX-011, a Dual-Acting Local Anesthetic Combining Bupivacaine and Meloxicam, as the Foundation of Non-Opioid Multimodal Analgesia." In this study, 77% of patients receiving HTX-011, along with postoperative over-the-counter (OTC) oral acetaminophen and ibuprofen, remained opioid-free through the 72-hour period following surgery and continued to be opioid-free through 28 days of recovery. The mean pain intensity never rose above the mild range through 72 hours postoperatively.

HTX-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 (EPOCH 1 in bunionectomy and EPOCH 2 in hernia repair) significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard--of--care local anesthetic for postoperative pain control. HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.

"A bunionectomy is a very painful surgical procedure that often requires opioids, which can come with adverse side effects, including nausea, vomiting, constipation and slowed breathing in addition to being potentially addictive," said Richard Pollak, M.D., DPM, a podiatric surgery specialist at San Antonio Podiatry Associates and an author of the publication. "Our findings from this study suggest that HTX-011 can serve as the foundation of a non-opioid multimodal analgesic (MMA) regimen, providing profound pain reduction and enabling opioid-free recovery for most bunionectomy patients through the 28-day recovery period."

The Journal of the American Podiatric Medical Association article can be found here.