Heron : FDA Oks ZYNRELEF Indication Expansion To Include Addl. Orthopedic & Soft Tissue Procedures

(RTTNews) - The U.S. Food and Drug Administration has approved Heron Therapeutics Inc.'s (HRTX) supplemental New Drug Application for ZYNRELEF (bupivacaine and meloxicam) extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided.

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

According to the company, the expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures. To obtain the labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty.

The company noted that ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution, the current standard-of-care. 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.

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