DURECT Corporation announces FDA approval of Posimir for post-surgical pain reduction for up to 72 hours following arthroscopic subacromial decompression.

DURECT Corporation announced that the 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 randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated over the first 72 hours after surgery versus placebo. Posimir demonstrated a statistically significant improvement in both primary outcome measures: a 1.3 point, or 20%, reduction in mean pain intensity on a 0-10 point pain scale (p=0.01), and a 67% reduction in I.V. morphine-equivalent rescue opioid use, from a median of 12 mg in the placebo group to 4 mg in the Posimir group (p=0.01). "In my experience, Posimir was easy to administer into the subacromial space under arthroscopic guidance, where it can directly address the source of postsurgical pain," said Sten Rasmussen, MD CBE PhD, Associate Professor, Department of Orthopaedic Surgery, Aalborg University Hospital, and Professor and Head of the Department of Clinical Medicine, Aalborg University, Denmark, a principal investigator in the POSIMIR registration trial. "A non-opioid product providing up to three days of local analgesia would be a significant benefit to patients.".