Heron Therapeutics Announces Publication of Results from HOPE (Helping Opioid Prescription Elimination), Showing ZYNRELEF Minimizes the Need for Opioids in a Real-World Setting, With 95% of Patients E

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 results from the HOPE Hernia-1 study of ZYNRELEF (bupivacaine and meloxicam) in hernia repair surgery have been published online by Pain and Therapy in an article entitled, "Opioid-Free Recovery After Hernia Repair With HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting." In this study, ZYNRELEF, used with scheduled over-the-counter oral analgesics (acetaminophen and ibuprofen) and a personalized opioid prescription algorithm in a real-world environment, enabled more than 90% of patients to be discharged without an opioid prescription, with no callbacks for pain management and 95% of patients to recover opioid-free.

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.

"Despite efforts to combat the nation's growing opioid crisis, recent evidence suggests that clinical practice is lagging and opioids are still overprescribed after inguinal herniorrhaphy," said Jay Redan, M.D., FACS, Chief of Surgery at Advent Health-Celebration in Celebration, Florida and an author of the publication. "The findings from this study demonstrate the ability of ZYNRELEF to serve as the foundation of non-opioid multimodal analgesia. These data also show ZYNRELEF, in conjunction with an algorithm that distinguishes between patients who need or do not need a discharge opioid prescription, could further increase the proportion of opioid-free patients, decrease the amount of opioids required per patient, and decrease the total number of opioid pills prescribed at discharge after surgery."

The study, HOPE Hernia-1, is part of the HOPE project, which is designed to provide surgeons with practical real-world solutions to effectively manage postoperative pain and eliminate the need for opioid prescriptions using ZYNRELEF as the foundation of a scheduled non-opioid multimodal analgesic regimen.

About Helping Opioid Prescription Elimination (HOPE) Study 

The study, Helping Opioid Prescription Elimination Hernia-1 (HOPE Hernia-1), is part of the HOPE project, which is designed to provide surgeons with practical real-world solutions to effectively manage postoperative pain and eliminate the need for opioid prescriptions using a ZYNRELEF-based non-opioid multimodal analgesia (MMA) regimen. All patients received oral ibuprofen 400 mg and acetaminophen 1 g approximately 2 hours before surgery and at the end of surgery all patients received intraoperative ZYNRELEF (300 mg bupivacaine/9 mg meloxicam) administered via needle-free application into the surgical site after final irrigation and suction of fascial layers and prior to suturing. The study randomized patients into two cohorts receiving non-opioid multimodal analgesia regimens - concurrent versus alternating ibuprofen and acetaminophen - following herniorrhaphy. A personalized algorithm determined eligibility for an opioid prescription at discharge: Numeric rating scale (NRS) pain score ≥6 and/or receipt of a postoperative opioid prior to discharge.

About ZYNRELEFTM for Postoperative Pain

ZYNRELEF is the first and only dual-acting local anesthetic (DALA) that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first modified-release local anesthetic to be classified by FDA as an "extended-release" product because ZYNRELEF is also the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was approved by the U.S. Food and Drug Administration (FDA) in May 2021 for use 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. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is 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. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients.