Heron: Approval of ZYNRELEF® Vial Access Needle Application

Heron Therapeutics, Inc., a biotechnology company based in San Diego, announced that the U.S. Food and Drug Administration (FDA) has received its Prior Approval Supplement (PAS) application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of September 23, 2024, for this application.

If the VAN is approved, it would replace the current vented vial spike, potentially simplifying aseptic preparation and significantly reducing ZYNRELEF's withdrawal time from up to three minutes to just twenty to forty-five seconds. The design of the VAN is intended to enhance the safety and ease of use of ZYNRELEF, potentially increasing its adoption and improving the preparation process. If approved, the VAN is expected to be available by the fourth quarter of this year.

Heron Therapeutics is also making progress with its national rollout in partnership with CrossLink Life Sciences, LLC. This partnership is set to add approximately 650 representatives to the promotion of ZYNRELEF by the end of the year. Heron believes this collaboration will be crucial in successfully introducing the VAN to a broad range of orthopedic surgeons across the United States.

Craig Collard, Heron's Chief Executive Officer, expressed enthusiasm about the FDA's acknowledgment of the VAN submission and the assigned four-month review period. He is optimistic that the combination of CrossLink's integration and the launch of the VAN will lead to wider adoption of ZYNRELEF in various surgical procedures.

ZYNRELEF is the first and only dual-acting local anesthetic that combines bupivacaine and meloxicam. It is designed to provide extended pain relief and has shown in Phase 3 studies to significantly reduce pain and the need for opioids in the first 72 hours after surgery, compared to bupivacaine, the current standard for postoperative pain management. Initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to provide postsurgical analgesia, ZYNRELEF's indication was expanded in December 2021 to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. In January 2024, the FDA approved its use in soft tissue and orthopedic procedures, including foot and ankle surgeries.

However, ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), which can increase the risk of heart attacks, strokes, gastrointestinal bleeding, ulcers, and tears. It should not be used during heart bypass surgery or by individuals allergic to any of its components or similar medications. Additionally, ZYNRELEF is not recommended for use as a paracervical block or during childbirth.

The most common side effects include vomiting for soft tissue procedures and constipation and headache for orthopedic procedures. The medications in ZYNRELEF can affect the nervous and cardiovascular systems, liver, and kidneys, and may reduce the effectiveness of some blood pressure medications. They should be avoided in individuals with severe heart failure and can cause adverse effects on cartilage, rare blood disorders, or severe allergic reactions. ZYNRELEF may also harm an unborn baby if administered after 20 weeks of pregnancy and can cause anemia.

Patients should discuss their medical conditions and all medications they are taking with their healthcare provider to determine if ZYNRELEF is appropriate for them.

Heron Therapeutics is dedicated to creating and commercializing innovative therapeutic solutions that enhance medical care, especially in acute care and oncology. The company leverages its advanced science, patented technologies, and innovative drug discovery and development approach to improve patient outcomes.