Posimir® (bupivacaine solution) is now available for postsurgical analgesia for up to 72 hours following arthroscopic subacromial decompression.
Posimir is a novel formulation of bupivacaine, an amide local anesthetic, designed to be administered into the subacromial space under direct arthroscopic visualization. The depot product uses a sucrose-based biodegradable matrix (sucrose acetate isobutyrate) that allows for bupivacaine to be released into the adjacent tissues over the course of 72 hours.
The approval of Posimir was based on data from a randomized, assessor-blinded, placebo-controlled study in 107 patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. Patients were randomly assigned 2:1:1 to receive Posimir, vehicle placebo, or bupivacaine HCl 50mg, and all patients received general anesthesia. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered, both evaluated over the first 72 hours after surgery, compared with placebo.
Results showed that treatment with Posimir demonstrated a significant 20% reduction in mean pain intensity (1.3 points on a 0-10 point pain scale) compared with placebo (P =.01). Additionally, Posimir was associated with a 67% reduction in intravenous morphine-equivalent rescue opioid use (median of 12 mg in the placebo arm vs 4 mg in the Posimir arm [P =.01]).
The most common adverse reactions reported with Posimir administration in shoulder surgery were dizziness, dysgeusia, dysuria, headache, hypoesthesia, paresthesia, tinnitus, and vomiting.
The clinical program for Posimir also included studies involving patients undergoing open and laparoscopic abdominal procedures, abdominal hysterectomy, and inguinal hernia repair. Adequate evidence of effectiveness was not demonstrated in any soft tissue procedure evaluated. Following Posimir administration in soft tissue surgical procedures, the most common adverse reactions reported were anemia, bradycardia, constipation, C-reactive protein increased, diarrhea, dizziness, dysgeusia, headache, nausea, post procedural contusion (bruising), procedural pain, pruritus, pyrexia, somnolence, surgical site bleeding, visible bruising, and vomiting.
The safety and efficacy of Posimir have not been established in other surgical procedures, including soft tissue surgical procedures, other orthopedic procedures, including for intra-articular administration, and boney procedures, or when used for neuraxial or peripheral nerve blockade. Posimir carries a Boxed Warning regarding the risk of potential adverse embolic effects resulting from inadvertent intravascular injection. It is contraindicated for use in patients undergoing obstetrical paracervical block anesthesia.
Posimir is supplied in 5 mL single-dose vials containing 660 mg of bupivacaine solution. The product is ready to use and does not require dilution or mixing.
This article originally appeared on MPR
- Innocoll and DURECT announce US launch of Posimir®. News release. Innocoll Pharmaceuticals Limited and DURECT Corporation. Accessed September 26, 2022. https://www.prnewswire.com/news-releases/innocoll-and-durect-announce-us-launch-of-posimir-301632764.html
- Posimir. Package insert. Innocoll Pharmaceuticals Limited; 2022. Accessed September 26, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204803Orig1s001lbl.pdf