FDA approval of the Prior Approval Supplement Application for Zynrelef (bupivacaine + meloxicam extended release) Vial Access Needle ("VAN")- Heron Therapeutics

The VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing Zynrelef 's withdrawal time down to between twenty and forty-five seconds. The user-friendly "container-like" design of the VAN may enhance the safe use of Zynelef, increase adoption, and improve the preparation process.

"With this approval, we are providing healthcare providers with a new mechanism that directly addresses one of Zynrelef 's adoption hurdles and will help reduce preparation time for surgical staff," said Bill Forbes, PharmD, Executive Vice President, Chief Development Officer at Heron. "Reducing patients' pain during the first three days after surgery is critical for patient recovery and well-being following often painful procedures, and we anticipate the VAN will lead to increased Zynrelef  adoption, positively impacting patient recovery."

"The VAN approval, along with Zynrelef 's January label expansion, its inclusion in the proposed 2025 Non-Opioid Policy for Pain Relief ("NOPAIN Act"), and the continued integration of our partnership with CrossLink Life Sciences, LLC ("CrossLink"), are all exciting milestones achieved during 2024 contributing to Zynrelef 's continued progress," said Craig Collard, Chief Executive Officer at Heron. "We remain optimistic about the potential transformative impact the VAN will have, following its expected launch in Q4 2024, providing healthcare professionals with an easier to use, versatile, and effective solution for managing postoperative pain across a wide range of surgical procedures."