Heron Therapeutics Gets FDA Nod for ZYNRELEF® Vial Access Needle

Heron Therapeutics, Inc., a biotechnology company based in San Diego, has announced that the U.S. Food and Drug Administration (FDA) has approved its Prior Approval Supplement Application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN. This new VAN will replace the existing vented vial spike, potentially simplifying the aseptic preparation process and reducing the withdrawal time for ZYNRELEF to between 20 and 45 seconds. The design of the VAN, which resembles a container, is expected to improve the safe use of ZYNRELEF, facilitate its adoption among healthcare providers, and streamline the preparation process.

Bill Forbes, PharmD, Executive Vice President and Chief Development Officer at Heron, emphasized that this approval addresses a significant hurdle in ZYNRELEF's adoption and will aid in reducing preparation time for surgical staff. Forbes highlighted the importance of managing patients' pain during the initial three days post-surgery for their recovery and well-being. He expressed optimism that the VAN will lead to greater adoption of ZYNRELEF, benefiting patient recovery.

Craig Collard, Chief Executive Officer at Heron, noted that the VAN approval is a key milestone alongside ZYNRELEF's label expansion in January, its inclusion in the proposed 2025 Non-Opioid Policy for Pain Relief (NOPAIN Act), and the ongoing integration with CrossLink Life Sciences, LLC. Collard expressed optimism about the transformative impact the VAN will have, particularly with its anticipated launch in the fourth quarter of 2024. He believes it will provide healthcare professionals with a more user-friendly, versatile, and effective solution for managing postoperative pain across various surgical procedures.

ZYNRELEF is notable for being the first and only dual-acting local anesthetic that delivers a fixed-dose combination of bupivacaine and a low dose of meloxicam. In Phase 3 studies, ZYNRELEF demonstrated significant pain reduction and increased the proportion of patients who did not require opioids in the first 72 hours post-surgery compared to bupivacaine solution, the current standard for postoperative pain management. Initially approved by the FDA in May 2021 for specific surgical procedures, ZYNRELEF received an expanded indication in December 2021, allowing its use in additional types of surgeries. Further approval in January 2024 extended its use to various soft tissue and orthopedic procedures.

Patients should be aware that ZYNRELEF contains an NSAID, which can increase the risk of heart attack or stroke, especially with prolonged use or higher doses. It is not suitable for use during heart bypass surgery and can increase the risk of gastrointestinal issues such as bleeding and ulcers. Patients allergic to components of ZYNRELEF, similar local anesthetics, NSAIDs, or those who have had adverse reactions to these medications, should avoid its use. It is also not recommended as a paracervical block during childbirth.

Common side effects of ZYNRELEF include vomiting for soft tissue procedures and constipation and headache for orthopedic procedures. The combination of a local anesthetic and an NSAID in ZYNRELEF can affect the nervous and cardiovascular systems, potentially causing liver or kidney problems, reducing the efficacy of some blood pressure medications, and should be avoided in cases of severe heart failure. Other risks include adverse effects on cartilage, rare blood disorders, severe skin or allergic reactions, harm to an unborn baby if administered after 20 weeks of pregnancy, and anemia.

Patients should discuss their medical history and current medications with their healthcare provider to determine if ZYNRELEF is appropriate for them. For medical advice about side effects, patients should contact their healthcare provider or report side effects to Heron or the FDA.

Heron Therapeutics, Inc. is dedicated to improving patient care through therapeutic innovations. The company's advanced science, patented technologies, and innovative approach have enabled them to develop and commercialize a range of products aimed at enhancing the standard of care for acute and oncology patients.