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: 14 Nov 2017
At a glance
- Drugs Bupivacaine (Primary)
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors Pacira Pharmaceuticals
- 14 Nov 2017 According to a Pacira Pharmaceuticals media release, U.S. Food and Drug Administration (FDA) has notified the company that its supplemental New Drug Application (sNDA) for EXPAREL as a nerve block for regional analgesia will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). The Prescription Drug User Fee Act (PDUFA) goal date for completion of review by FDA of April 6, 2018.
- 14 Nov 2017 According to a Pacira Pharmaceuticals media release, the positive data of this and another phase III trial (see CT 269388), safety and pharmacokinetic data from eight company-sponsored studies through 120 hours, and data from two investigator-initiated studies that provide additional experience peripheral nerve block comparator studies will serve as the basis of an sNDA fillind, seeking expansion of the EXPAREL label to include administration via nerve block.
- 18 Oct 2017 According to a Pacira Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL (bupivacaine liposome injectable suspension) label to include administration via nerve block for prolonged regional analgesia.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History