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A Phase 3, Randomized, Double-Blind, Multicenter, Active-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered Via Adductor Canal Block for Postsurgical Analgesia in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty

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Trial Profile

A Phase 3, Randomized, Double-Blind, Multicenter, Active-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered Via Adductor Canal Block for Postsurgical Analgesia in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Nov 2023

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At a glance

  • Drugs Bupivacaine (Primary)
  • Indications Anaesthesia
  • Focus Pharmacokinetics; Registrational
  • Sponsors Pacira BioSciences
  • Most Recent Events

    • 10 Nov 2023 According to a Pacira BioSciences media release, U.S. Food and Drug Administration (FDA) has approved supplemental new drug application (sNDA) to expand the EXPAREL (bupivacaine liposome injectable suspension) label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa, based on data from two phase 3 studies (NCT05157841 and NCT05139030).
    • 07 Sep 2022 According to a Pacira BioSciences media release, the company plans to submit the full results from this study for presentation at future scientific conferences and for publication in a peer-reviewed journal.
    • 07 Sep 2022 According to a Pacira BioSciences media release, based on the results of this study, the company plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration early next year seeking expansion of the EXPAREL label to include femoral nerve block in the adductor canal.
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