Business
Heron Therapeutics Announces Acceptance of the Prior Approval Supplement Application for ZYNRELEF® Vial Access Needle ("VAN")
-The U.S. Food and Drug Administration ("FDA") assigned a Prescription Drug User Fee Act ("PDUFA") goal date of September 23, 2024 SAN DIEGO, July 2, 2024
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"-The U.S. Food and Drug Administration (\"FDA\") assigned a Prescription Drug User Fee Act (\"PDUFA\") goal date of September 23, 2024\nSAN DIEGO, July 2, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) (\"Heron\" or the \"Company\"), a commercial-stage biotechnology company, today announced that the FDA acknowledged the receipt of the Company's Prior Approval Supplement (\"PAS\") application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN. The FDA has assigned a PDUFA goal date of September 23, 2024.\nIf approved, the introduction of 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 from up to three minutes down to between twenty and forty-five seconds. The user-friendly \"container-like\" design of the VAN may enhance the safe use of ZYNRELEF, increase adoption, and improve the preparation process. If approved, the VAN is expected to be available for use in the fourth quarter of this year.\nIn addition to the anticipated launch of the VAN, the national rollout of the CrossLink Life Sciences, LLC (\"CrossLink\") partnership continues to make progress and is expected to add ~650 representatives to the promotion of ZYNRELEF by year-end. The Company anticipates that this partnership will be instrumental in successfully launching the VAN to a large base of orthopedic surgeons across the country.\n\"The acknowledgement of the VAN submission and corresponding designation of a four-month review for ZYNRELEF is exciting and we look forward to working with the FDA during the application review process,\" said Craig Collard, Chief Executive Officer at Heron. \"With the continued integration of CrossLink and the launch of the VAN, we are optimistic about the potential for more accounts to adopt ZYNRELEF as an essential part of their surgical procedures.\"\nAbout ZYNRELEF for Postoperative Pain\nZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids th...