FDA Expands Bupivacaine and Meloxicam (Zynrelef) Approval to Include Additional Orthopedic and Soft Tissue Procedures

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On January 23, 2024, Heron Therapeutics announced the FDA had approved its sNDA for bupivacaine and meloxicam extended-release solution to expand the indication to include soft tissue and orthopedic surgical procedures, including procedures in which direct exposure to articular cartilage is avoided.

FDA Approves Bupivacaine and Meloxicam

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved an expanded indication for bupivacaine and meloxicam (Zynrelef) to include soft tissue and orthopedic surgical procedures.1

Announced on January 23, 2024, the approval comes almost 3 years after the agent, which is billed as the only extended-release, dual-acting local anesthetic designed to deliver a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug meloxicam, received initial approval from the FDA and expands the indication to include procedures in which direct exposure to articular cartilage is avoided.

"Patients undergoing orthopedic procedures often experience severe pain, slowing down their recovery time and potentially leading to other complications. Reducing patients' pain within the first three days is critical for patient satisfaction, and having a product like ZYNRELEF now available for additional orthopedic procedures is a great benefit to have in my practice," said Alexander Sah, MD, orthopedic surgeon at Sah Orthopaedic Associates. "ZYNRELEF helps my patients recover fully, be discharged sooner, and have significantly less pain, with little to no opioid use."

In December 2022, Heron Therapeutics, Inc. submitted a supplemental New Drug Application (sNDA) to expand the indication to soft tissue and orthopedic surgical procedures. The application was based on a comparison of safety and pharmacokinetic data from the more recent trials evaluating total shoulder arthroplasty, spinal surgery, C-section, and abdominoplasty, and the initial safety and efficacy trials.3

It is currently indicated for adults for up to 72 hours following foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.4

Although safety and efficacy have not been assessed in highly vascular surgeries, including intrathoracic, large multilevel spinal, and head and neck procedures, the most common adverse reactions post-administration are headache, vomiting, and constipation.4

"The expanded indication is poised to have a transformative impact on patient care, providing healthcare professionals with a versatile and effective solution for managing postoperative pain across an even wider range of surgical procedures. The new label expansion and recent partnership with CrossLink, combined with the potential approval of the Vial Access Needle ("VAN") later this year, are expected to have a significant positive impact for ZYNRELEF and the Company," said Craig Collard, chief executive officer of Heron.

References

  1. [Actual reference]
  2. Heron Therapeutics announces U.S. FDA approval of ZYNRELEFTM (HTX-011) for the management of postoperative pain for up to 72 hours. Heron Therapeutics. May 13, 2021. Accessed January 22, 2024. https://herontherapeutics.gcs-web.com/news-releases/news-release-details/heron-therapeutics-announces-us-fda-approval-zynreleftm-htx-011.
  3. Heron Therapeutics announces filing of an efficacy supplement for ZYNRELEF® and provision in newly passed Congressional bill anticipated to provide separate reimbursement outside of the packaged surgical payment for zynrelef. Heron Therapeutics. December 29, 2022. Accessed January 22, 2024. https://ir.herontx.com/news-releases/news-release-details/heron-therapeutics-announces-filing-efficacy-supplement.
  4. Heron Therapeutics announces partnership with Crosslink Life Sciences to expand promotional effort for ZYNRELEF®, the first and only non-opioid dual acting local anesthetic for post-operative pain. Heron Therapeutics. January 7, 2024. Accessed January 22, 2024. https://ir.herontx.com/news-releases/news-release-details/heron-therapeutics-announces-partnership-crosslink-life-sciences.
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