HopeHOPE: Helping Opioid Prescription Elimination.

ZYNRELEF as the foundation of a non-opioid MMA regimen in a real-world setting1

In Part 1 of the initial HOPE study, HOPE Hernia 1, patients undergoing open inguinal herniorrhaphy were randomized to 1 of 2 parallel cohorts, each receiving different postoperative non-opioid MMA regimens with ZYNRELEF as the foundation.1,2

  • Cohort 1 (n = 46): Alternating OTC regimen (ibuprofen 600 mg every 6 hours alternated 3 hours later with acetaminophen 1 g every 6 hours)
  • Cohort 2 (n = 47): Concurrent OTC regimen (ibuprofen 600 mg and acetaminophen 1 g, taken together every 6 hours)
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HOPE Hernia 1 Study Design
 

A simple algorithm was used to identify which patients were more likely to require postoperative opioid pain control:3

  • Patients with a Numeric Rating Scale (NRS) score ≥6 within 2 hours after surgery
  • Patients who required any postoperative opioids prior to discharge

This algorithm was prospectively validated in HOPE Hernia 1.

Following administration of ZYNRELEF, if additional NSAID medication is indicated in the postoperative period, monitor patients for signs and symptoms of NSAID-related GI adverse reactions.

Note: The results in this presentation reflect Part 1 of the initial HOPE study in herniorrhaphy. Part 1 of this study was open label, with 2 parallel cohorts receiving different postoperative non-opioid MMA regimens.

95% of ZYNRELEF patients were opioid-free through day 15 of recovery1

Of herniorrhaphy patients treated with ZYNRELEF 300 mg/9 mg and scheduled non-opioid oral OTC analgesic regimens (N = 93)1:

Chart: 89% to 94% discharged without opioids. 96% to 98% opioid-free postdischarge. 91% to 98% opioid-free through day 15.
ZYNRELEF Alternatingb MMA (n = 46)
ZYNRELEF Concurrentc MMA (n = 47)
aThrough day 15, 1 patient who received a discharge opioid prescription called the site for postoperative pain. bAlternating: OTC regimen of ibuprofen 600 mg every 6 hours alternated 3 hours later with acetaminophen 1 g every 6 hours. cConcurrent: OTC regimen of ibuprofen 600 mg and acetaminophen 1 g, taken together every 6 hours. MMA: multimodal analgesia. OTC: over-the-counter.

High patient satisfaction with both MMA regimens1

Satisfaction assessed at day 15. Each of the 3 domains shown included 3 questions.

Chart: Effectiveness: 84% and 79% satisfaction. Convenience: 89% and 86% satisfaction. Global satisfaction: 86% and 82%.
ZYNRELEF Alternatinga MMA (n = 46)
ZYNRELEF Concurrentb MMA (n = 47)
aAlternating: OTC regimen of ibuprofen 600 mg every 6 hours alternated 3 hours later with acetaminophen 1 g every 6 hours. bConcurrent: OTC regimen of ibuprofen 600 mg and acetaminophen 1 g, taken together every 6 hours. MMA: multimodal analgesia. OTC: over-the-counter. TSQM-9: Nine-item Treatment Satisfaction Questionnaire for Medication.4

Extrapolating HOPE data: HOPE for an estimated 21 million fewer opioid pills2,5,6

Only 8 of the 93 patients in HOPE Hernia 1 received an opioid prescription at discharge. Of those 8 patients, only 3 took any opioids after discharge.2

Opioid pill bottle.

There are 750,000 herniorrhaphy surgeries in US annually, with an average of 30 opioid pills per prescription.5,6

'22.5M' above pill icon.

That equals 22.5 million opioid pills per year.5,6

'91%' icon.

91% of patients treated with ZYNRELEF + OTC analgesics received no discharge opioid prescription.2

20.5M fewer prescription opioid pills.

ZYNRELEF + OTC analgesics could replace over 20.5 million opioid pills for herniorrhaphy alone.2,5,6

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Important Safety Information and Indication

Indication

ZYNRELEF 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.

Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Important Safety Information

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Contraindications

ZYNRELEF is contraindicated in patients with known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to any amide local anesthetic, NSAIDs, or other components of ZYNRELEF; with history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (severe, sometimes fatal, anaphylactic reactions to NSAIDS have been reported in such patients); undergoing obstetrical paracervical block anesthesia; or undergoing coronary artery bypass graft (CABG) surgery.

Warnings and Precautions

Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after application of ZYNRELEF. When using ZYNRELEF with other local anesthetics, overall local anesthetic exposure must be considered through 72 hours.

Hepatotoxicity: If abnormal liver tests persist or worsen, perform a clinical evaluation of the patient.

Hypertension: Patients taking some antihypertensive medication may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

Heart Failure and Edema: Avoid use of ZYNRELEF in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ZYNRELEF in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal failure.

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.

Methemoglobinemia: Cases have been reported with local anesthetic use.

Serious Skin Reactions: NSAIDs, including meloxicam, can cause serious skin adverse reactions. If symptoms present, evaluate clinically.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): If symptoms are present, evaluate clinically.

Fetal Toxicity: Due to the risk of oligohydramnios/fetal renal dysfunction and premature closure of the ductus arteriosus with NSAIDS, limit use of ZYNRELEF between about 20 to 30 weeks gestation, and avoid use after about 30 weeks.

Hematologic Toxicity: Monitor hemoglobin and hematocrit in patients with any signs or symptoms of anemia.

Drug Interactions

Drugs That Interfere with Hemostasis: Monitor patients for bleeding who are using ZYNRELEF with drugs that interfere with hemostasis (eg, warfarin, aspirin, SSRIs/SNRIs). 

ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Beta-Blockers: Use with ZYNRELEF may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

ACE Inhibitors and ARBs: Use with ZYNRELEF in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.

Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effect.

Use in Specific Populations

Infertility: NSAIDs are associated with reversible infertility. Consider avoidance of ZYNRELEF in women who have difficulties conceiving.

Severe Hepatic Impairment: Only use if benefits are expected to outweigh risks; monitor for signs of worsening liver function.

Severe Renal Impairment: Not recommended.

Adverse Reactions

Most common adverse reactions (incidence ≥10%) in controlled clinical trials with ZYNRELEF are constipation, vomiting, and headache.

Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication

ZYNRELEF 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.

Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Please see full Prescribing Information, including Boxed Warning.

References: 1. Fanikos J, Minkowitz H, Reinhorn M, Quart B. HTX-011 as the foundation of a non-opioid, multimodal analgesic regimen reduces the need for opioids following herniorrhaphy in a real-world study. Poster presented at: American Society of Health-System Pharmacists 2019 Midyear Clinical Meeting & Exhibition; December 9, 2019; Las Vegas, NV. 2. Data on file. Study HTX-011-304. San Diego, CA: Heron Therapeutics Inc; 2019. 3. Data on file. Algorithm to limit opioid prescriptions after administering HTX-011. San Diego, CA: Heron Therapeutics Inc; 2020. 4. Bharmal M, Payne K, Atkinson MJ, Desrosiers M-P, Morisky DE, Gemmen E. Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications. Health Qual Life Outcomes. 2009;7:36. doi:10.1186/1477-7525-7-36. 5. Data on file. DRG procedure volume analysis. San Diego, CA: Heron Therapeutics Inc; 2018. 6. Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide variation and excessive dosage of opioid prescriptions for common general surgical procedures. Ann Surg. 2017;265(4):709-714. doi:10.1097/SLA.0000000000001993.