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New option offers improved postoperative pain management while reducing the need for opioids

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(BPT) - Ahead of surgery, it is normal to have a running list of questions. Those questions likely include learning more about the surgical procedure, the possible complications, and the pain following surgery. When you begin this conversation with your surgical team, it is important to learn more about your options to manage the pain following surgery and make a game plan as this is a critical piece of your recovery. Medical professionals have various ways to treat pain and help you remain as comfortable as possible as your body heals after surgery, but some of these options, such as opioids (OxyContin, Percocet, Percodan), come with risks, which may result in unpleasant side effects and even addiction.

September is Pain Awareness Month and an important time to better understand different options for treating post-surgical pain safely and effectively. Poorly controlled pain can have negative outcomes and delay patient recovery. Opioid medication is a common way to treat pain after surgery, however, opioids often lead to adverse reactions, ranging from potentially severe adverse events to the risk of long-term use, misuse, and addiction. ZYNRELEF™ (bupivacaine and meloxicam) is a new non-opioid alternative for postoperative pain relief that also enables less reliance on or even eliminates the need for opioids after surgery.

Understanding post-surgical pain

Discomfort can vary depending on many factors, including the type of surgery, but you can typically expect pain after a surgery due to the production of an inflammatory response to incisions at the surgical site. This inflammation intensifies pain signals and increases the acidity in the tissues in the surgical wound.1-3 The first 72 hours after surgery are typically the most painful. Inflammation peaks around 24 hours postoperatively and remains relatively high through the first 72 hours.4-6

A surgeon will often inject a local anesthetic at the incision site to help block pain.7 Because tissue acidity decreases the ability of most local anesthetics to penetrate nerve cells and block pain signals, efficacy is often limited beyond 12-24 hours.1-3With severe pain often lasting through 72 hours, this leaves a gap in postoperative pain management where health care providers often rely on opioids.1,5,8

Risks of opioid use

Recent data from the Centers for Disease Control and Prevention (CDC) show that the deadly opioid epidemic is getting worse with more than 92,000 Americans dying of drug overdoses in 2020, which is an almost 30 percent increase from 2019.9

More than 50 million surgical procedures happen annually in the United States10 and 67% of patients filled an opioid prescription between 30 days before through 14 days after surgery.11 Opioids can be an effective method for managing pain, but they can cause an increased number of opioid-related adverse events such as constipation, breathing problems, nausea, and vomiting. They can also lead to longer term impacts such as chronic postsurgical pain, persistent opioid use, and opioid use disorder. Even just a 7-day course of opioids can increase the risk for addiction by more than two times versus a one-day course.12 It is important to prevent the overreliance on opioids in the postoperative setting as it can have unintended downstream consequences for patients, communities, and the nation’s ongoing epidemic.

Ask about alternatives

If you or a loved one has an upcoming surgery, ask your doctor about options for managing pain and alternatives to opioids, including the new extended-release dual-acting local anesthetic, ZYNRELEF.

ZYNRELEF is the first and only extended-release dual-acting local anesthetic approved by the FDA for use in adults to reduce pain for up to three days after removal of bunions, groin hernia repair and total knee replacement.13 ZYNRELEF is applied directly to the impacted tissue by a doctor during surgery and has been clinically shown to better manage pain including severe pain than standard-of-care bupivacaine over 72 hours and to significantly reduce opioid use in many patients following surgery.13-15

Like all medications, there are side effects, in this case, ZYNRELEF contains a low dose of the NSAID (non-steroidal anti-inflammatory drug) meloxicam, a type of medicine which:13

  • 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.

In clinical trials, 51% of hernia repair patients and 29% of bunionectomy patients required no opioids through 72 hours post-surgery with ZYNRELEF alone.14-15 Of ZYNRELEF patients who required no opioids through 72 hours, more than 90% remained opioid-free through day 10 and more than 80% remained opioid-free through day 28 recovery.14-15 Additional data in a real-world setting following hernia repair surgery in the HOPE Project: Part 1, showed that ZYNRELEF in combination with scheduled over-the-counter pain medicines, such as acetaminophen and ibuprofen, resulted in opioid-free recovery for the majority of patients.16 Ninety-five percent of patients were opioid-free at discharge and remained opioid-free through day 15 recovery.16 Additionally, 91 percent of patients received no opioid discharge prescription; among these patients, none called back to request one.16

Understanding what to expect after a surgery is important. Discuss the best methods for managing surgical pain for you and ask your healthcare provider about non-opioid alternatives. Please find the full prescribing information including boxed warning at ZYNRELEF.com

Important Safety Information

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.
  • 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).

Tell your healthcare provider about all your medical conditions and about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements to discuss if ZYNRELEF is right for you.

Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The information provided here is not comprehensive. Please see full Prescribing Information, including Boxed Warning.

References:

  1. Kim et al. The role of liposomal bupivacaine in reduction of postoperative pain after transforaminal lumbar interbody fusion: a clinical study. World Neurosurg. 2016;91:460-467. doi:10.1016/j. wneu.2016.04.058.
  2. Becker DE, Reed KL. Essentials of local anesthetic pharmacology. Anesth Prog. 2006;53(3):98-109. doi:10.2344/0003-3006(2006)53[98:EOLAP]2.0.CO;2.
  3. Hargreaves et al. Local anesthetic failure in endodontics: mechanisms and management. Endod Topics. 2002;1(1):26-39. doi:10.1034/j.1601-1546.2002.10103.x.
  4. Svensson et al. Assessment of pain experiences after elective surgery. J Pain Symptom Manage. 2000;20(3):193-201.doi:10.1016/S0885-3924(00)00174-3.
  5. Enoch S, Leaper DJ. Basic science of wound healing. Surgery (Oxford). 2008;26(2):31-37. doi:10.1016/j.mpsur.2007.11.005.
  6. Woolf CJ. Pain: moving from symptom control toward mechanism-specific pharmacologic management. Ann Intern Med. 2004;140(6):441-451. doi:10.7326/0003-4819-140-8-200404200-00010.
  7. Golf M et al. A phase 3, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Therapy. 2011;28(9):776-788. doi:10.1007/s12325-011-0052-y
  8. Ali et al. Doubtful effect of continuous intraarticular analgesia after total knee arthroplasty: a randomized, double-blind study of 200 patients. Acta Orthop. 2015;86(3):373-377. doi:10.3109/17453674.2014.991629
  9. Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2021.
  10. Brummett CM, Waljee JF, Goesling J, et al. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017;152(6):e170504. doi:10.1001/jamasurg.2017.0504.
  11. Santosa KB, Hu HM, Brummett CM, et al. New Persistent Opioid Use Among Older Patients Following Surgery: A Medicare Claims Analysis. Surgery. 2020;167(4):732-742. doi:10.1016/j.surg.2019.04.016.
  12. Shah A, Hayes CJ, Martin BC. Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use — United States, 2006–2015. MMWR Morb Mortal Wkly Rep. 2017;66:265-269. doi:10.15585/mmwr.mm6610a1.
  13. ZYNRELEF [Package Insert]. San Diego, CA: Heron Therapeutics Inc.; 2021.
  14. Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee G-C. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019;44(7):700-706. doi:10.1136/rapm-2019-100531.
  15. Viscusi E, Minkowitz H, Winkle P, Ramamoorthy S, Hu J, Singla N. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study. Hernia. 2019;23(6):1071-1080. doi:10.1007/s10029-019-02023-6.
  16. 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.

09/2021 PP-HTX011-0607


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