Approval of Zynrelef by Health Canada for the management of postoperative pain – Heron Therapeutics

Heron Therapeutics, Inc., announced that Health Canada has issued a Notice of Compliance (NOC) to commercialize Zynrelef (bupivacaine and meloxicam extended-release solution) for instillation into the surgical wound for postoperative analgesia after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty surgical procedures. Based on prior agreements with the FDA, Heron already has clinical studies underway, which it plans to submit to Health Canada to expand the indication statement.

Zynrelef is the first and only extended-release bupivacaine product approved in Canada. It is a dual-acting fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam. The meloxicam in Zynrelef is associated with an increase in the analgesic effect of bupivacaine, resulting in patients experiencing significantly less pain, including severe pain, after surgery as compared to bupivacaine solution, the current standard-of-care.