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 Experiencing an Opioid-free Recovery
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
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.
The Pain and Therapy article can be found here.
Important Safety Information for Patients
ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which:
- can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID.
- cannot be used during heart bypass surgery.
- can increase the risk of gastrointestinal bleeding, ulcers, and tears.
ZYNRELEF should also not be used if you are allergic to any components of ZYNRELEF, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines; or as a paracervical block, during childbirth.
The most common side effects of ZYNRELEF are constipation, vomiting, and headache.
The medicines in ZYNRELEF (a local anesthetic and an NSAID) can affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia). Please see full Prescribing Information, including Boxed Warning.
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. Key results of the study include the following:
- The majority of patients (85/93; 91.4%) did not receive an opioid prescription at discharge or at any time through 2 weeks after surgery, and the results were similar between cohorts (alternating MMA, 89.1%; concurrent MMA, 93.6%).
- Overall, 94.6% of patients were opioid-free through the 2-week follow-up period.
- The mean discharge time following surgery was 2.6 hours in the alternating MMA cohort and 2.2 hours in the concurrent MMA cohort.
- Of the 98% of patients who completed the TSQM-9, most patients were "very" or "extremely" satisfied with their MMA regimen.
ZYNRELEF plus acetaminophen and ibuprofen was well tolerated; safety results were similar between concurrent and alternating MMA cohorts.
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
About Heron Therapeutics, Inc.
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, the timing of the commercial launch of ZYNRELEF in Europe; the potential market opportunity for ZYNRELEF in the US and
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