FDA Approves Indication Expansion For Heron Therapeutics' Post-Op Pain Med

The FDA has approved Heron Therapeutics Inc's HRTX supplemental application for Zynrelef (bupivacaine and meloxicam) extended-release solution to expand the indication. 

• Zynrelef is now indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.
• Zynrelef demonstrated superior, sustained postoperative pain relief for up to 72 hours and decreased the need for opioids, with more patients opioid-free compared to bupivacaine solution.
• This expanded indication for Zynrelef will now cover approximately 7 million procedures annually. 
• Heron plans to submit a second supplemental application to the FDA in 2H of 2022 to support a broad indication for soft tissue and orthopedic surgical procedures, intended to cover the full 14 million target procedures.
• Price Action: HRTX shares are up 16.10% at $9.69 during the market session on the last check Thursday.