Heron Therapeutics, Inc. announced on September 25, 2024, that the U.S. Food and Drug Administration (FDA) approved its Prior Approval Supplement Application for the ZYNRELEF (bupivacaine and meloxicam) extended-release solution Vial Access Needle (VAN). This approval marks a significant step in enhancing the usability of ZYNRELEF, a dual-acting local anesthetic for postoperative pain.
The newly approved VAN is designed to replace the existing vented vial spike, aiming to simplify aseptic preparation and substantially reduce ZYNRELEF's withdrawal time to between twenty and forty-five seconds. This improvement addresses a key operational challenge previously identified as an adoption hurdle for healthcare providers.
Management anticipates that the user-friendly 'container-like' design of the VAN will enhance the safe use of ZYNRELEF, increase its adoption among surgical staff, and improve the overall preparation process. The VAN is expected to launch in the fourth quarter of 2024, contributing to ZYNRELEF's continued progress alongside its January label expansion and inclusion in the proposed 2025 NOPAIN Act.
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