FDA accepts resubmission of Exparel for prolonged regional analgesia.- Pacira Pharmaceuticals.

Pacira Pharmaceuticals, Inc. announced the 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. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is April 6, 2018.

The sNDA is based on the positive data from a Phase III study of Exparel in femoral nerve block for TKA (lower extremity) and a Phase III study of Exparel in brachial plexus block for shoulder surgeries (upper extremity). It also includes safety and pharmacokinetic data through 120 hours.

Eight Pacira-sponsored studies support this expanded indication. In total, 570 subjects received a dose of Exparel ranging from 2 mg to 310 mg. In addition, the sNDA includes data from two investigator-initiated studies that provide additional experience in smaller, peripheral nerve block settings..