FDA approval of Zynrelef indication expansion to include additional orthopedic and soft tissue procedures

Zynrelef was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.

This expanded indication for Zynrelef will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures. To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. No unique safety issues were identified from the new clinical trials, and the bupivacaine and meloxicam blood concentrations were consistent with previous experience following Zynrelef administration.

"The expanded indication is poised to have a transformative impact on patient care, providing healthcare professionals with a versatile and effective solution for managing postoperative pain across an even wider range of surgical procedures. The new label expansion and recent partnership with CrossLink, combined with the potential approval of the Vial Access Needle ("VAN") later this year, are expected to have a significant positive impact for Zynrelef and the Company," said Craig Collard, Chief Executive Officer of Heron.

Zynrelef is the first and only therapy for postoperative pain management to be rigorously tested in Phase III studies and demonstrate superiority to bupivacaine solution, the current standard-of-care. Zynrelef demonstrated superiority compared to bupivacaine with 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 of the first supplemental NDA for an expanded label in December 2021.

"Patients undergoing orthopedic procedures often experience severe pain, slowing down their recovery time and potentially leading to other complications. Reducing patients' pain within the first three days is critical for patient satisfaction, and having a product like Zynrelef now available for additional orthopedic procedures is a great benefit to have in my practice," said Alexander Sah, M.D., orthopedic surgeon at Sah Orthopaedic Associates. "Zynrelef helps my patients recover fully, be discharged sooner, and have significantly less pain, with little to no opioid use."