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ESRA19-0684 Reduction in proportion of subjects with severe pain following herniorrhaphy using HTX-011 as the foundation of a multimodal analgesic regimen
  1. N Singla1,
  2. B Quart2,
  3. J Evans-Shields3,
  4. J Hu4 and
  5. J Redan5
  1. 1Lotus Clinical Research, Chief Executive Officer, Pasadena, USA
  2. 2Heron Therapeutics, Inc., Chief Executive Officer and Director, San Diego, USA
  3. 3Heron Therapeutics, Inc., Medical Affairs, San Diego, USA
  4. 4Heron Therapeutics, Inc., Biostatistics, San Diego, USA
  5. 5Advent Health and University of Central Florida, Surgery, Celebration, USA


Background and aims HTX-011 is a novel, dual-acting, extended-release local anesthetic comprising bupivacaine and low-dose meloxicam in a Biochronomer® polymer. In a phase 3 herniorrhaphy study, HTX-011 alone provided superior pain relief and resulted in more opioid-free subjects through 72 hours than placebo or bupivacaine hydrochloride. This follow-on study evaluates HTX-011 as the foundation of a non-opioid multimodal analgesic (MMA) regimen following herniorrhaphy.

Methods This open-label study enrolled subjects undergoing open inguinal herniorrhaphy into two sequential cohorts. In both cohorts, subjects received acetaminophen 1000mg preoperatively, HTX-011 300mg/9mg (bupivacaine/meloxicam) intraoperatively via needle-free application, and postoperative scheduled MMA regimen of alternating oral acetaminophen 1000mg and oral ibuprofen 600mg, every 6 hours. Cohort 2 subjects also received intraoperative intravenous ketorolac. Prespecified endpoints included the proportion of opioid-free subjects and subjects in severe pain (numeric rating scale [NRS] ≥7 on a 0–10 scale) at any time through 72 hours.

Results 63 subjects were enrolled. Mean pain scores never rose above mild pain (NRS <4) through 72 hours. the proportion of subjects who experienced severe pain was low (17.5%) and more than 90% of subjects remained opioid-free through 72 hours. the addition of intravenous ketorolac did not demonstrate additional pain relief or reduction in opioid use. HTX-011 and the MMA regimen were well-tolerated; there was no evidence of non-steroidal anti-inflammatory drug-related toxicities.

Conclusions The use of HTX-011 as the foundation of a non-opioid MMA regimen is safe and resulted in a low proportion of subjects who experienced severe pain, enabling a high proportion of subjects to be opioid-free following herniorrhaphy.

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