Benzinga | Feb 2, 2021 08:05AM EST

DURECT Corporation Announces FDA Approval Of POSIMIR For Post-Surgical Pain Reduction For Up To 72 Hours Following Arthroscopic Subacromial Decompression

CUPERTINO, Calif., Feb. 2, 2021 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that the U.S. Food and Drug Administration (FDA) has approved POSIMIR(r) (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). Please see important safety information including the Boxed Warning below and the POSIMIR full prescribing information.