The Food and Drug Administration (FDA) has approved the supplemental New Drug Application for Zynrelef® (bupivacaine and meloxicam) extended-release solution to include a broader group of surgical procedures.
Zynrelef is now indicated for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. It is a dual-acting local anesthetic that delivers a fixed-dose combination of bupivacaine, an amide local anesthetic, and meloxicam, a nonsteroidal anti-inflammatory drug. The needle-free product is intended for single-dose administration only.
In May 2021, the FDA approved Zynrelef for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. The approval was based on data from phase 3 and phase 2 studies, which demonstrated superior, sustained postoperative pain relief for up to 72 hours and decreased the need for opioids compared with bupivacaine solution. Use in these related surgical procedures was supported by data from these trials.
“With this label expansion, Zynrelef is now indicated in significantly more surgeries per year, enabling more institutions to consider therapeutic substitution for a broad range of surgical procedures,” said Barry Quart, PharmD, Chairman and Chief Executive Officer of Heron.
Zynrelef extended-release solution is available in 4 dosage strengths in single-dose vials: 400mg bupivacaine/12mg meloxicam, 300mg bupivacaine/9mg meloxicam, 200mg bupivacaine/6mg meloxicam, and 60mg bupivacaine/1.8mg meloxicam.
- Heron Therapeutics announces FDA approval of a significant indication expansion for Zynrelef®. News release. Heron Therapeutics, Inc. Accessed December 9, 2021. https://www.prnewswire.com/news-releases/heron-therapeutics-announces-fda-approval-of-a-significant-indication-expansion-for-zynrelef-301440851.html.
- Zynrelef. Package insert. Heron Therapeutics, Inc.; 2021. Accessed December 9, 2021. https://zynrelef.com/prescribing-information.pdf.
Source: Medical Bag https://www.medicalbag.com/home/news/zynrelef-indication-expanded-to-include-more-surgical-procedures/