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Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the XaraColl Bupivacaine Implant (300 mg Bupivacaine Hydrochloride) After Open Laparotomy Hernioplasty

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Trial Profile

Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the XaraColl Bupivacaine Implant (300 mg Bupivacaine Hydrochloride) After Open Laparotomy Hernioplasty

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2021

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At a glance

  • Drugs Bupivacaine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Acronyms MATRIX-2
  • Sponsors Innocoll

    • Most Recent Events

    • 31 Aug 2020 According to an Innocoll media release, the company look forward to sharing data with surgeons as they introduce new option to manage acute pain following open inguinal hernia repair in adults.
    • 31 Aug 2020 According to an Innocoll media release, the US Food and Drug Administration (FDA) has approved Xaracoll for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair
    • 26 Mar 2020 According to an Innocoll media release, the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) resubmission for XARACOLL (bupivacaine hydrochloride collagen-matrix implants), for the management of postsurgical pain after open inguinal hernia surgery. The FDA set a PDUFA goal date of August 26, 2020.

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