Pacira Pharma Submits SNDA In Nerve Block Indication For Exparel

(RTTNews) - Pacira Pharmaceuticals, Inc. (PCRX) announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for a nerve block indication for Exparel or bupivacaine liposome injectable suspension.

The sNDA is based on positive data from a Phase 3 study assessing the safety and efficacy of Exparel in femoral nerve block for total knee arthroplasty. It will also include additional safety data from a Phase 3 study of Exparel used to perform an intercostal nerve block for thoracotomy.

The timeline for review of the sNDA, under the Prescription Drug User Fee Act, is 10 months. If the FDA accepts the sNDA filing, a PDUFA target date of March 5, 2015 is expected.