Pacira BioSciences, Inc. announced that the company’s Marketing Authorization Application (MAA) for Exparel (bupivacaine liposome injectable suspension) for postsurgical analgesia was validated by the European Medicines Agency (EMA). With this validation, the Pacira application is complete and the EMA Committee for Medicinal Products for Human Use (CHMP) will now begin the review procedure with an opinion expected in the second half of 2020.
The MAA for Exparel is supported by clinical evidence across several surgical indications, including patients undergoing Cesarean section and total knee arthroplasty procedures. In December 2018, the EMA issued a positive opinion for the company’s Pediatric Investigation Plan (PIP) for Exparel for postsurgical analgesia. Exparel is indicated in the U.S. for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Since its launch, Exparel has been used in over five million patients.