Posted by Michael Wonder on 03 Feb 2021
Durect Corporation announces U.S. FDA approval of Posimir for post-surgical pain reduction for up to 72 hours following arthroscopic subacromial decompression
2 February 2021 - POSIMIR is the only approved sustained release bupivacaine product indicated for up to 72 hours of post-surgical analgesia from a single application.
Durect Corporation today announced that the U.S. FDA has approved Posimir (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.
The approval was based on positive data from a randomised, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff.
