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HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study

Authors
  • Viscusi, E.1
  • Minkowitz, H.2
  • Winkle, P.3
  • Ramamoorthy, S.4
  • Hu, J.5
  • Singla, N.6
  • 1 Sidney Kimmel Medical College of Thomas Jefferson University, 111 South 11th Street, Gibbon Building, Suite 8490, Philadelphia, PA, 19107, USA , Philadelphia (United States)
  • 2 HD Research Corp, Houston, TX, USA , Houston (United States)
  • 3 Anaheim Clinical Trials, Anaheim, CA, USA , Anaheim (United States)
  • 4 University of California at San Diego Health System, San Diego, CA, USA , San Diego (United States)
  • 5 Heron Therapeutics, Inc., San Diego, CA, USA , San Diego (United States)
  • 6 Lotus Clinical Research, LLC, Pasadena, CA, USA , Pasadena (United States)
Type
Published Article
Journal
Hernia
Publisher
Springer Paris
Publication Date
Aug 19, 2019
Volume
23
Issue
6
Pages
1071–1080
Identifiers
DOI: 10.1007/s10029-019-02023-6
Source
Springer Nature
Keywords
License
Green

Abstract

PurposeCurrently available local anesthetics have not demonstrated sufficient analgesia beyond 12–24 h postoperatively. The purpose of the study was to assess the safety and efficacy of HTX-011 (bupivacaine and meloxicam in Biochronomer® polymer technology), a long-acting investigational anesthetic, in reducing both postoperative pain over 72 h and postoperative opioid use compared to bupivacaine hydrochloride (HCl).MethodsA phase 3, randomized, double-blind, active-controlled multi-center study (EPOCH 2; NCT03237481) in subjects undergoing unilateral open inguinal herniorrhaphy with mesh placement was performed. Subjects randomly received a single intraoperative dose of HTX-011, immediate-release bupivacaine HCl, or saline placebo prior to closure.ResultsThe study evaluated 418 subjects, and the primary and all key secondary efficacy endpoints were in favor of HTX-011. HTX-011 reduced mean pain intensity by 23% versus placebo (primary endpoint; p < 0.001) and by 21% versus bupivacaine HCl (p < 0.001) with significant reductions in the number of patients experiencing severe pain. Opioid consumption over 72 h was reduced by 38% versus placebo (p < 0.001) and 25% versus bupivacaine HCl (p = 0.024). Overall, 51% of HTX-011 subjects were opioid-free through 72 h (versus 22% for placebo [p < 0.001] and 40% for bupivacaine HCl [p = 0.049]). HTX-011 was generally well-tolerated with fewer opioid-related adverse events reported compared to the bupivacaine HCl and placebo and no evidence of local anesthetic systemic toxicity.ConclusionsHTX-011 demonstrated significant improvement in postoperative pain control and a clinically meaningful reduction in opioid consumption when compared to the most widely used local anesthetic, bupivacaine HCl.

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