New Nonopioid for Post-Surgical Pain Reduction Granted FDA Approval
The drug is a novel, nonopioid, sustained-release local analgesic indicated for use as postsurgical analgesia for up to 72 hours.
Officials with the FDA have approved bupivacaine solution (Posimir; DURECT Corporation) for infiltration use in adults.
The drug is a novel, nonopioid, sustained-release local analgesic indicated for use as postsurgical analgesia for up to 72 hours following arthroscopic subacromial decompression. It is administered into the subacromial space under direct arthroscopic visualization.
"The first 72 hours after surgery are typically when patients experience the most severe postsurgical pain," said T J Gan, MD, MHS, FRCA, MBA, professor and distinguished endowed chair, Department of Anesthesiology at Stony Brook University Renaissance School of Medicine, in a prepared statement. "So, a new sustained-release product providing continuous analgesia during this critical period is a welcome addition to the armamentarium for anesthesiologists and surgeons, especially as we aim to reduce the use of postsurgical opioids whenever possible."
According to DURECT, 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. Bupivacaine solution 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 IV 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).
The label for bupivacaine solution includes a boxed warning. The warning cautions about risk of potential adverse embolic effects from inadvertent intravascular injection, which could cause droplets of the drug to be deposited in the pulmonary and other capillary beds.
Unintended intravascular injection of bupivacaine solution may be associated with systemic toxicities, including central nervous system or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Bupivacaine solution should also be used cautiously in patients with impaired hepatic and cardiovascular function.
Adverse events (AEs) reported in clinical trials with an incidence greater than or equal to 10% and greater than control following bupivacaine solution administration in shoulder surgery were dizziness, dysgeusia, dysuria, headache, hypoesthesia, paresthesia, tinnitus, and vomiting. AEs reported with an incidence greater than or equal to 10% and greater than control following administration of bupivacaine solution in soft tissue surgical procedures were anemia, bradycardia, constipation, C-reactive protein increased, diarrhea, dizziness, dysgeusia, headache, nausea, oropharyngeal pain, postprocedural contusion, procedural pain, pruritus, pyrexia, somnolence, surgical site bleeding, visible bruising and vomiting.
DURECT Corporation Announces U.S. FDA Approval of POSIMIR For Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression [news release]. February 2, 2021; Cupertino, CA: DURECT. Accessed February 2, 2021. https://investors.durect.com/news-releases/news-release-details/durect-corporation-announces-us-fda-approval-posimirr-post.