The Truth Shouldn’t Hurt

Watch this video to hear Lucy S. Hostetter, MD thoughts on Heron’s investigational drug, HTX-011

FACT-CHECKING THE NEW “LONG-ACTING LOCALS” (LALs).

While the urgency to find opioid-sparing pain relief for the post-op setting has led to the development of newer options, both fixed-dose EXPAREL and HTX-011^† take a “one size fits all” approach to pain relief.

ARE THESE LALs AS SAFE AND EFFECTIVE AS THEY CLAIM? LET’S TAKE A LOOK TO SEE HOW THEY STACK UP TO ON-Q*

Safety of EXPAREL and HTX-011 is not fully understood:

• Neither LAL can be adjusted or turned off if complications arise and effectiveness of lipid rescue is unknown^1,2
• The nonadjustable dose of bupivacaine and meloxicam in HTX-011 raises new questions about local infiltration of NSAIDs.² Will this local NSAID be overkill at the site? Might it suppress inflammatory responses key to the healing process or increase bleeding risk?

EXPAREL and HTX-011 efficacy results are coming up short:

• EXPAREL was found NOT to offer significant benefits over standard local anesthetics in recent reviews of the clinical data^3-9
• It appears the efficacy claims of HTX-011 are based on averages of patients’ pain scores instead of more clinically relevant continuous data²

Claims of reducing opioids are not fully supported:

• Studies have shown that opioid use is significantly greater with EXPAREL than with local anesthetics^10-13
• With only two stage 3 clinical trials reported, conclusions cannot be made about HTX-011 and opioid use across multiple surgical specialties¹⁴

†HTX-011 is an investigational formulation of bupivacaine and meloxicam from Heron Therapeutics

1. Ilfeld BM. Liposome bupivacaine in peripheral nerve blocks and epidural injections to manage postoperative pain. Expert Opin Pharmacother. 2013;14(17):2421-2431.
2. Heron Therapeutics. Company Update January 2019. https://herontherapeutics.gcs-web.com/static-files/7a7ec637-9158-4949-a09d-1bdcdd1f6c37. Published January 7, 2019. Accessed February 27, 2019.
3. VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives. Bupivacaine liposome injectable suspension (Exparel®) update. https://www.pbm.va.gov/PBM/ clinicalguidance/drugmonographs/Bupivacaine_Liposome_Injectable_Suspension_EXPAREL_Evidence_Update_2016.pdf Published March 2016. Accessed February 18, 2019.
4. Noviasky J, Pierce D, Whalen K, Guharoy R, Hildreth K. Bupivacaine liposomal versus bupivacaine: comparative review. Hosp Pharm. 2014 Jun; 49(6):539–543.
5. Alijanipour P, Tan TL, Matthews CN, et al. Periarticular injection of liposomal bupivacaine offers no benefit over standard bupivacaine in total knee arthroplasty: a prospective, randomized, controlled trial. J Arthroplasty. 2017;32(2):628-634.
6. Amundson AW, Johnson RL, Abdel MP, et al. A three-arm randomized clinical trial comparingcontinuous femoral plus single-injection sciatic peripheral nerve blocks versus periarticular injection with ropivacaine or liposomal bupivacaine for patients undergoing total knee arthroplasty. Anesthesiology. 2017;126(6):1139-1150.
7. Jain RK, Porat MD, Klingenstein GG, Reid JJ, Post RE, Schoifet SD. The AAHKS clinical research award: liposomal bupivacaine and periarticular injection are not superior to single-shot intra-articular injection for pain control in total knee arthroplasty. J Arthroplasty. 2016;31(9S):22-25.
8. DeClaire JH, Aiello PM, Warritay OK, Freeman DC. Effectiveness of bupivacaine liposome injectable suspension for postoperative pain control in total knee arthroplasty: a prospective, randomized, double blind, controlled study. J Arthroplasty. 2017;32(9S):S268-S271.
9. Kopp SL, Børglum J, Buvanendran A, et al. Anesthesia and analgesia practice pathway options for total knee arthroplasty: an evidence-based review by the American and European Societies of Regional Anesthesia and Pain Medicine. Reg Anesth Pain Med. 2017;42(6):683-697.
10. Namdari S, Nicholson T, Abboud J, Lazarus M, Steinberg D, Williams G. Randomized Controlled Trial of Interscalene Block Compared with Injectable Liposomal Bupivacaine in Shoulder Arthroplasty. J Bone Joint Surg Am. 2017 Apr 5;99(7):550-556.
11. Namdari S, Nicholson T, Abboud J,Lazarus M, Steinberg D, Williams G. Interscalene Block with and without Intraoperative Local Infiltration with Liposomal Bupivacaine in Shoulder Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2018 Aug 15;100(16):1373-1378.
12. Amundson AW, Johnson RL, Abdel MP, et al. A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. Anesthesiology. 2017 Jun;126(6):1139-1150.
13. Abildgaard JT, Lonergan KT, Tolan SJ, et al. Liposomal bupivacaine versus indwelling interscalene nerve block for postoperative pain control in shoulder arthroplasty: a prospective randomized controlled trial. J Shoulder Elbow Surg. 2017 Jul;26(7):1175-1181.
14. Heron Therapeutics. 90% of Patients Remain Opioid-Free When HTX-011 Is Given with an Over-the-Counter Analgesic Regimen in New Multi-center Postoperative Pain Management Study. https://herontherapeutics.gcs-web.com/newsreleases/news-release-details/90-patients-remain-opioid-free-when-htx-011-given-over-counter. Published January 3, 2019. Accessed February 18, 2019.

There are inherent risks in all medical devices. Please refer to the product labeling for Indications, Cautions, and Warnings and Contraindications. Failure to follow the product labeling could directly impact patient safety. Physician is responsible for prescribing and administering medications per instructions provided by the drug manufacturer. Refer to www.avanos.com for product safety Technical Bulletins.

*Registered Trademark or Trademark of Avanos Medical, Inc., or its affiliates. ©2019 AVNS. All rights reserved. COPY-03219 2/19