NEWS
Heron Therapeutics Announces Prior Approval Supplement Submission to the FDA for ZYNRELEF® Vial Access Needle ("VAN")
Heron Therapeutics announced the submission of a Prior Approval Supplement (PAS) to the FDA for the ZYNRELEF Vial Access Needle (VAN). The VAN aims to replace the current vented vial spike (VVS) in ZYNRELEF kits, reducing preparation time significantly from up to 3 minutes to 20-45 seconds. The VAN's user-friendly design is expected to simplify aseptic preparation and potentially increase adoption. FDA review completion is anticipated within 4-6 months. ZYNRELEF, approved in May 2021, is noted for its efficacy in postoperative pain management compared to bupivacaine solution, showing lower pain scores and reduced opioid consumption.
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