FDA advisory committee votes against expanded indication for Pacira's Exparel

Pacira Pharmaceuticals Inc. (NASDAQ:PCRX) said FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 6-4 against approval of a resubmitted sNDA for Exparel bupivacaine (depobupivacaine) as a nerve block to produce regional analgesia. Its PDUFA date is April 6. The six members who voted no said more research would be required to support the sNDA.

Pacira received a complete response letter for the product 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, March 9, 2015)...