Heron Therapeutics Submits FDA Supplement for ZYNRELEF® Vial Access Needle

Heron Therapeutics, Inc., a leading biotechnology company listed on Nasdaq as HRTX, has announced the submission of a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) for ZYNRELEF®, which combines bupivacaine and meloxicam for extended-release pain relief. This submission aims to introduce a new Vial Access Needle (VAN) to replace the current Vented Vial Spike (VVS) in the ZYNRELEF kit, enhancing the preparation process for healthcare providers.

Heron expects the FDA to assign an action date for this PAS review within the next few weeks, with a final decision anticipated within four to six months. The new VAN is designed to simplify the aseptic preparation of ZYNRELEF, reducing product withdrawal time from up to three minutes to just twenty to forty-five seconds. This user-friendly design could potentially improve the adoption of ZYNRELEF and ensure safer usage during postoperative pain management.

The decision to develop the VAN was based on feedback from healthcare providers who requested an easier and more efficient preparation process for ZYNRELEF. Dr. Bill Forbes, Executive Vice President and Chief Development Officer at Heron, emphasized the potential of this innovation to simplify clinical procedures and provide significant pain relief to more patients following surgery.

ZYNRELEF is notable for being the first therapy for postoperative pain rigorously tested in Phase 3 studies to show superiority over the standard bupivacaine solution. The findings demonstrated that ZYNRELEF resulted in lower pain scores, fewer instances of severe pain, and reduced opioid consumption. FDA approval was first granted in May 2021, with subsequent approvals for expanded labels in December 2021 and January 2024.

ZYNRELEF includes an NSAID, which poses certain risks. The NSAID component can increase the risk of heart attack or stroke, particularly with higher doses and prolonged use, and cannot be administered during heart bypass surgery. It also heightens the risk of gastrointestinal issues such as bleeding, ulcers, and tears. Patients with allergies to NSAIDs, local anesthetics, or those who have had adverse reactions to similar medications should avoid using ZYNRELEF. It is also not suitable for paracervical blocks or during childbirth.

Common side effects of ZYNRELEF include vomiting and constipation. The active ingredients may impact the nervous and cardiovascular systems, and could lead to liver or kidney problems. It is crucial for patients to inform their healthcare provider about their medical history and all medications they are taking to evaluate if ZYNRELEF is appropriate for them.

ZYNRELEF’s unique formulation combines a local anesthetic with an NSAID, delivering extended pain relief and reducing the need for opioids in the critical first 72 hours post-surgery. Since its initial FDA approval in May 2021, ZYNRELEF has expanded its indications to include various surgical procedures, demonstrating significant efficacy in reducing postoperative pain compared to traditional bupivacaine solutions.

Heron Therapeutics, headquartered in San Diego, focuses on advancing therapeutic innovations that improve patient care in acute and oncology settings. Their portfolio of products is designed to set new standards in medical care through advanced science and patented technologies.