HTX-011 Effectively Reduces Postoperative Pain Intensity and Opioid use in the Elderly

Abstract

Aim: HTX-011 (ZYNRELEF™) is an extended-release, dual-acting local anesthetic containing bupivacaine and meloxicam. In bunionectomy and herniorrhaphy studies, HTX-011 resulted in less postoperative pain and less opioid consumption versus bupivacaine HCl. Here we evaluate HTX-011 in patients aged ≥65 years. Materials & methods: Patients received placebo, bupivacaine HCl or HTX-011 following surgery. End points included pain intensity, total opioid consumption, opioid-free patients and safety. Results: HTX-011-treated patients reported lower postoperative pain through 72 h versus bupivacaine HCl and placebo. Elderly patients administered HTX-011 used fewer opioids versus bupivacaine HCl, and a greater proportion remained opioid-free through 72 h. HTX-011 was well tolerated with a safety profile similar to bupivacaine HCl and placebo. Conclusion: HTX-011 maintained effectiveness and was well tolerated in elderly patients.

Clinical Trial registration numbers: NCT03295721 and NCT03237481

Keywords::

• anesthetics
• geriatrics
• medication safety
• pain management
• pharmacokinetics

Author contributions

PS Hawn was responsible for study conception and design. A Yamamoto and J Hu were responsible for acquisition of data. All authors participated in data analysis and drafting and revision of the manuscript.

Acknowledgments

The authors thank the patients, investigators and study site personnel for their valuable contributions to this work.

Financial & competing interests disclosure

This study was funded by Heron Therapeutics, Inc. (San Diego, CA, USA). T Yip has nothing to disclose. J Hu is an employee of Heron Therapeutics, Inc., and reports personal fees during the conduct of the study and outside the submitted work. A Yamamoto is an employee of Heron Therapeutics, Inc. G Oderda is a consultant for Heron Therapeutics, Inc. PS Hawn was an employee of Heron Therapeutics at the time of manuscript submission. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Editorial and submission assistance was provided by S Dilks and L Raman of ApotheCom (San Francisco, CA, USA), and was funded by Heron Therapeutics, Inc. (San Diego, CA, USA).

Ethical conduct of research

The study protocols were approved by Aspire IRB (Santee, CA, USA) and other institutional review boards and were conducted in accordance with the International Council for Harmonisation Guidelines for Good Clinical Practice and the Declaration of Helsinki. All patients provided written informed consent prior to any study-related procedures.

Data sharing statement

The authors certify that this manuscript reports the secondary analysis of clinical trial data that have been shared with them, and that the use of these shared data is in accordance with the terms (if any) agreed upon their receipt. The source of these data is: ClinicalTrials.gov, NCT03295721 and NCT03237481. Data are available on reasonable request.

Additional information

Funding

This study was funded by Heron Therapeutics, Inc. (San Diego, CA, USA). T Yip has nothing to disclose. J Hu is an employee of Heron Therapeutics, Inc., and reports personal fees during the conduct of the study and outside the submitted work. A Yamamoto is an employee of Heron Therapeutics, Inc. G Oderda is a consultant for Heron Therapeutics, Inc. PS Hawn was an employee of Heron Therapeutics at the time of manuscript submission. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Editorial and submission assistance was provided by S Dilks and L Raman of ApotheCom (San Francisco, CA, USA), and was funded by Heron Therapeutics, Inc. (San Diego, CA, USA).