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: 15 Feb 2018
At a glance
- Drugs Bupivacaine (Primary)
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors Pacira Pharmaceuticals
- 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.
- 12 Feb 2018 According to a Pacira Pharmaceuticals media release, The U.S. Food and Drug Administration (FDA) has posted briefing materials for the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) meeting that will review the company's supplemental New Drug Application seeking expansion of the current EXPAREL.The briefing materials can be found on the FDA website.The Advisory Committee meeting is scheduled for February 14-15, 2018.
- 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.