Heron Therapeutics submits PAS for Zynrelef VAN

By Tamara Parker • Wednesday, May 29 15:13 • Permanent Link

Heron Therapeutics, Inc. (NASDAQ: HRTX) has announced the submission of a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) for Zynrelef® (bupivacaine and meloxicam) extended-release solution vial access needle ("VAN"). The company anticipates an action date on this PAS to be between four (4) and six (6) months.

The Zynrelef kit, which contains a ready-to-use vial and all necessary components for needle-free application to the patient, currently includes a vented vial spike ("VVS") that can take up to three (3) minutes to complete product withdrawal. If approved, the introduction of the VAN will replace the VVS and has the potential to significantly reduce Zynrelef's withdrawal time down to twenty (20) – forty-five (45) seconds, simplifying aseptic preparation and improving the preparation process.

Zynrelef is the first and only therapy for postoperative pain management to demonstrate superiority to bupivacaine solution, the current standard-of-care. It has shown lower pain scores, fewer patients experiencing severe pain, and lower opioid consumption. Zynrelef was initially approved by the FDA in May 2021, and received approval for expanded labels in December 2021 and January 2024.

The most common side effects of Zynrelef for soft tissue procedures are vomiting, and for orthopedic procedures, constipation and headache. Zynrelef contains an NSAID (non-steroidal anti-inflammatory drug) and has important safety information for patients, including potential risks related to heart attack or stroke, gastrointestinal bleeding, ulcers, and tears.

Zynrelef 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 the NSAID meloxicam. It has demonstrated significantly reduced pain and increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control.

Today the company's shares have moved -3.7% to a price of $3.29. Check out the company's full 8-K submission here.

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