Pacira Pharmaceuticals announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for an expanded nerve block indication for Exparel (bupivacaine) liposome injectable suspension.
The submission was based on positive data from a Phase 3 study assessing the safety and efficacy of Exparel in femoral nerve block for total knee arthroplasty. Pacira will also include additional safety data from a Phase 3 study of Exparel used to perform an intercostals nerve block for thoracotomy.
Exparel is already approved for single-dose infiltration into the surgical site to produce postsurgical analgesia.
For more information call (873) 254-3560 or visit Pacira.com.