FDA approves Pacira's sNDA for Exparel

Pacira Pharmaceuticals Inc. (NASDAQ:PCRX) said FDA approved an sNDA for Exparel bupivacaine as a nerve block administered via interscalene brachial plexus to produce regional analgesia in patients undergoing upper extremity surgeries.

In February, an FDA advisory committee voted 6-4 against approval of the sNDA, which Pacira had resubmitted following receipt of a complete response letter in 2015. The CRL said that while Pacira submitted data from one study showing efficacy in the setting of femoral nerve block, a second efficacy study failed to demonstrate efficacy for intercostal nerve block (see BioCentury, Feb. 16)...