- Heron Therapeutics Inc HRTX has submitted a Supplemental Marketing Authorization Application for Zynrelef (bupivacaine and meloxicam) as a prolonged-release solution to support the proposed indication for expanded use of Zynrelef in soft tissue orthopedic surgical interventions.
- Zynrelef is currently indicated in adults for soft tissue or periarticular instillation to provide postoperative analgesia for up to 72 hours following surgical procedures involving the feet and ankles, small to moderate sized open abdominal cavities, and lower extremity total joint arthroplasty.
- Related: Analysts cut price targets as Heron Therapeutics’ Zynrelef disappoints in Q3.
- The motion also supports newly passed Congressional legislation that is expected to provide separate reimbursement outside of the surgical lump sum payment for Zynrelef for nearly three years between January 1, 2025 and December 31, 2027.
- In two phase 3 studies, Zynrelef demonstrated the ability to significantly increase the proportion of patients who do not take opioids after surgery.
- The company says separate payments from CMS are expected to significantly accelerate the uptake of Zynrelef in large hospital systems.
- Price promotion: HRTX shares are up 6.00% on the last check Thursday to $2.39.
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