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Heron Therapeutics Announces Approval of ZYNRELEF® by Health Canada for the Management of Postoperative Pain
- ZYNRELEF is the first and only extended-release local anesthetic approved by Health Canada - SAN DIEGO, March 17, 2022 /PRNewswire/ -- Heron Therapeutics,
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"- ZYNRELEF is the first and only extended-release local anesthetic approved by Health Canada -\nSAN DIEGO, March 17, 2022 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today 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 U.S. Food and Drug Administration (FDA), Heron already has clinical studies underway, which we plan to submit to Health Canada to expand the indication statement.\nZYNRELEF 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.1\n\"The approval of ZYNRELEF in Canada marks another important regulatory milestone for Heron in our plans for increased global adoption of the product. With the continuing opioid crisis in Canada, we are well positioned with the only approved non-opioid, locally applied analgesic demonstrated to significantly reduce postoperative pain and opioid use,\" said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. \"With this approval, Heron will move forward with partnering discussions and submitting manufacturing supplements to Health Canada for large-scale suppliers of ZYNRELEF to significantly reduce ZYNRELEF's cost of goods. These manufacturing supplements have already been approved in the U.S. We will also work closely with Health Canada to expand the indications for ZYNRELEF in a similar fashion to what we have done with the FDA.\"\nZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies an...