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A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy

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Trial Profile

A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Mar 2025

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At a glance

  • Drugs Bupivacaine/meloxicam (Primary) ; Bupivacaine
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Acronyms EPOCH 1
  • Sponsors Heron Therapeutics

Most Recent Events

  • 23 Jan 2024 According to a Heron Therapeutics media release, the U.S. FDA has approved its supplemental NDA for ZYNRELEF extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. To obtain this labeling expansion, the company conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty.
  • 17 Mar 2022 According to a Heron Therapeutics media release, the Health Canada has issued a Notice of Compliance to commercialize ZYNRELEF for instillation into the surgical wound for postoperative analgesia after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty surgical procedures. Based on prior agreements with the U.S. FDA, company already has clinical studies underway, which company plans to submit to Health Canada to expand the indication statement.
  • 21 Jul 2021 Post-hoc analysis results from phase 3 EPOCH 1 and EPOCH 2 studies published in the Heron Media Release.

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