Heron Therapeutics, Inc. has announced that the US Food and Drug Administration (FDA) has approved the supplemental New Drug Application (NDA) for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution. 

The expanded indication covers soft tissue and orthopedic surgical procedures, including foot and ankle, and others avoiding direct exposure to articular cartilage. ZYNRELEF was previously approved for specific surgical procedures in adults, and this expansion is expected to encompass an estimated 13 million procedures annually, an 86 percent increase.

The expanded indication resulted from successful studies in various surgical procedures, including cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. No unique safety issues were identified, and bupivacaine and meloxicam blood concentrations remained consistent with previous ZYNRELEF administration.

Craig Collard, CEO of Heron, emphasized the transformative impact on patient care, providing healthcare professionals with a versatile solution for managing postoperative pain across a broader range of procedures. The approval is anticipated to have a significant positive impact on ZYNRELEF and the company, along with recent partnerships and potential approval of the Vial Access Needle later this year.

ZYNRELEF, the first therapy for postoperative pain management rigorously tested in Phase 3 studies, demonstrated superiority to bupivacaine solution, the current standard of care. Initial FDA approval was in May 2021, with the first supplemental NDA for an expanded label approved in December 2021. The product has shown lower pain scores, reduced severe pain instances, and lower opioid consumption compared to bupivacaine.

Orthopedic surgeon Dr. Alexander Sah highlighted the benefits of ZYNRELEF, stating it helps patients recover fully, facilitates earlier discharge, and significantly reduces pain with minimal opioid use. The expanded approval provides a valuable option for additional orthopedic procedures, contributing to improved patient satisfaction and recovery outcomes.