Data from Pharmawand - Curated by EPG Health - Date added 13 February 2018
Pacira Pharmaceuticals, Inc. announced that the 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 (bupivacaine liposome injectable suspension) label for infiltration to include use as a nerve block for regional analgesia.
The Advisory Committee meeting is scheduled for February 14-15, 2018. The sNDA filing is based on positive data from a Phase III study of Exparel in femoral nerve block for total knee arthroplasty (lower extremity) and a Phase III study of Exparel in brachial plexus block for shoulder surgeries (upper extremity). It includes data from eight company-sponsored studies with safety and pharmacokinetic data through 120 hours. In addition, the sNDA includes data from two investigator-initiated studies that provide additional experience in smaller, peripheral nerve block settings.
The Prescription Drug User Fee Act (PDUFA) date for completion of the FDA’s review of the company’s sNDA for ExparelL is April 6, 2018.