Heron announces PAS submission to FDA for ZYNRELEF

Heron Therapeutics announced the Prior Approval Supplement, or PAS, submission to the FDA for ZYNRELEF, or bupivacaine and meloxicam, extended-release solution Vial Access Needle, or VAN. Heron expects to receive the assigned action date for completion of the FDA’s review of this PAS within the next several weeks and anticipates an action date on this PAS to be between four and six months. The ZYNRELEF kit contains a ready-to-use vial and all necessary components for needle-free application to the patient. The current kit contains a vented vial spike, or VVS, which can take up to three minutes to complete product withdrawal, requiring coordination between both sterile and nonsterile personnel. If approved, the introduction of the VAN will replace the VVS and has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF’s withdrawal time down to twenty – 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. ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies. ZYNRELEF demonstrated superiority compared to bupivacaine with lower pain scores, fewer patients experiencing severe pain, and lower opioid consumption. ZYNRELEF was initially approved by the FDA in May 2021, received approval of the first supplemental New Drug Application, or sNDA, for an expanded label in December 2021, followed by the second sNDA for an expanded label in January.