FDA Advisory Committee does not approve Exparel to treat regional analgesia.- Pacira Pharma.
Pacira Pharmaceuticals, Inc. announced that the FDA Anesthetic and Analgesic Drug Products Advisory Committee did not reach a unanimous decision on the efficacy and safety of the use of Exparel (bupivacaine liposome injectable suspension) as a nerve block to produce regional analgesia. The committee�s feedback will be considered by the FDA in its review of the company�s sNDA seeking expansion of the Exparel label. The Prescription Drug User Fee Act (PDUFA) date for completion of the review is 6 April 2018.
Four committee members voted to recommend FDA approval of the Exparel sNDA while six believed that more research is needed to further support the proposed new indication. 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.
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