Benzinga | Jul 21, 2021 04:10PM EDT

Heron Therapeutics Announces Publication Showing Reduction of Pain and Opioid Use Compared to Bupivacaine in Patients 65 and Older with ZYNRELEF

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 the online publication of new analysis evaluating the efficacy and safety of ZYNRELEF (bupivacaine and meloxicam) extended-release solution in adults aged 65 years and older undergoing bunionectomy and hernia repair from the Phase 3 EPOCH 1 and EPOCH 2 studies. The analysis, published in the peer-reviewed journal Pain Management, showed that 58% of bunionectomy and 87% of hernia repair patients aged 65 years and older receiving ZYNRELEF required no opioids to manage their postoperative pain through 72 hours following surgery. Further, throughout the 72-hour period, the mean pain intensity never rose above the mild range.

ZYNRELEF is an extended-release solution of bupivacaine and meloxicam that is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.

In this post-hoc analysis, those 65 years and older who were administered ZYNRELEF used fewer opioids in bunionectomy and herniorrhaphy compared with bupivacaine (7.7 morphine milligram equivalents (MME) vs 15 MME, and 1.7 MME vs 3.5 MME, respectively). Importantly, a greater proportion of patients 65 years and older required no opioids (i.e., opioid-free) through 72 hours (58% vs 25%, and 87% vs 64%, respectively).

ZYNRELEF was well tolerated in patients 65 years and older, with a safety profile similar to that for bupivacaine. The safety was also similar to patients aged younger than 65 years and to the overall populations in the Phase 3 studies. No local anesthetic systemic toxicity events occurred and serious adverse events were rare with none considered related to ZYNRELEF.

"Adults ages 65 and over account for approximately half of all surgeries in the United States each year and are commonly prescribed opioids to treat pain following surgery," said Gary M. Oderda, Pharm.D., MPH, Professor, Director Utah Medicaid Drug Regimen Review Center & Director, Pharmacotherapy Outcomes Research Center, and an author of the publication. "In addition, as people age, medications affect them more strongly and are slower to leave their systems, so the side effects of opioids can be severe. This analysis shows ZYNRELEF demonstrated reduction in both pain and the need for opioids in those 65 years and older, which could eliminate the risks of taking opioids without compromising patient care."

ZYNRELEF is the first and only local anesthetic that has been clinically shown to significantly reduce pain, including severe pain, better than bupivacaine, the current standard-of-care, for up to 72 hours and to significantly reduce or eliminate opioid use in many patients following surgery.

The Pain Management article can be found here.