FDA Approves Posimir for Postsurgical Analgesia

The Food and Drug Administration (FDA) has approved Posimir^® (bupivacaine solution; Durect) for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical 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 directly into the surgical site. 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 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 (IV) morphine-equivalent rescue opioid use (median of 12mg in the placebo arm vs 4mg 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. Following Posimir administration in soft tissue surgical procedures, the most common adverse reaction included 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.

“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 3 days of local analgesia would be a significant benefit to patients.”

Posimir is supplied in 5mL single-dose vials containing 660mg of bupivacaine solution. The product is expected to be available sometime in the second half of 2021.

References

1.    Durect Corporation announces U.S. FDA approval of Posimir® for post-surgical pain reduction for up to 72 hours following arthroscopic subacromial decompression. [press release]. Cupertino, CA: Durect Corporation; February 2, 2021. 

2.    Posimir [package insert]. Cupertino, CA: Durect Corporation; 2021.