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
Phase of Trial: Phase III
Latest Information Update: 09 Apr 2018
At a glance
- Drugs Bupivacaine (Primary)
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors Pacira Pharmaceuticals
- 09 Apr 2018 Results published in a Pacira Pharmaceuticals Media Release.
- 09 Apr 2018 Pacira received U.S. Food and Drug Administration (FDA) approval for its supplemental new drug application for EXPAREL as a nerve block to produce regional analgesia, based on positive data from this phase 3 study of EXPAREL in brachial plexus block for shoulder surgeries, according to a Pacira Pharmaceuticals media release.
- 15 Feb 2018 According to a Pacira Pharmaceuticals media release, The U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee did not reach an unanimous decision on the efficacy and safety of the use of EXPAREL, as a nerve block to produce regional analgesia. The FDA will consider this feedback, to review the company's sNDA seeking expansion of the EXPAREL label.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History