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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Shoulder Arthroplasty or Rotator Cuff Repair

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Shoulder Arthroplasty or Rotator Cuff Repair

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2023

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At a glance

  • Drugs Bupivacaine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Pacira Pharmaceuticals

    • Most Recent Events

    • 29 Mar 2023 According to a Pacira BioSciences media release, the expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is November 13, 2023
    • 18 Nov 2020 According to a Pacira BioSciences media release, based on four pivotal Phase 3 studies (402C326, 402C327, SKY0402C317, SKY0402C316), the European Commission has granted marketing authorization for EXPAREL as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults.
    • 04 Jun 2019 According to an Pacira BioSciences Media Release, results from this study which included significant reductions in pain and opioids were published in Pain Medicine.
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