A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Femoral Nerve Block With EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty
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 269389), safety and pharmacokinetic data from eight company-sponsored studies through 120 days and 120 hours, 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, this resubmission of sNDA is based on the positive data of this study, another phase III trial (700269388), eight company-sponsored studies which includes safety and pharmacokinetic data through 120 hours and two investigator-initiated studies which provide additional experience in smaller, peripheral nerve block settings.