Posimir effective for Postsurgical Analgesia approved by FDA
POSIMIR, a bupivacaine solution by the Durect Corporation recently got its approval from the FDA for Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression.
POSIMIR (bupivacaine solution) for infiltration, use is a novel and proprietary product that combines the strength of 660 mg of bupivacaine base with the innovative SABER® platform technology, enabling continuous sustained delivery of a non-opioid local analgesic over 3 days in adults. POSIMIR contains more bupivacaine than any other approved single-dose sustained-release bupivacaine product. At the end of the surgery, POSIMIR is administered into the subacromial space under direct arthroscopic visualization, where it continuously releases bupivacaine for 72 hours or more.
Sten Rasmussen and colleagues from the Department of Orthopaedic Surgery, Aalborg University Hospital, Denmark conducted 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.
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