Heron Therapeutics Announces FDA Approval of a Significant Indication Expansion for ZYNRELEF®
Heron Therapeutics, Inc., a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution to significantly 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 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 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. With this approval, the FDA has confirmed that the superior efficacy demonstrated for ZYNRELEF in the pivotal trials supports its use in a broader group of related surgical procedures.
This expanded indication for ZYNRELEF will now cover approximately 7 million procedures annually. The use of ZYNRELEF in the additional procedures offers surgeons the opportunity to further reduce their patients need for opioids following surgery, which can positively impact the patients and limit the postoperative discharge opioids that can lead to misuse. Postoperative opioids have been shown to be a doorway to addiction with over 2 million Americans becoming persistent opioid users after receiving opioids following surgery. According to the Centers for Disease Control and Prevention, the highest number of overdose deaths on record occurred during the 12-month period ending April 2021, with over 100,000 American lives lost.
"The FDA approved the label expansion based on the strength of the ZYNRELEF clinical data in less than 6 months after our successful initial launch and only a little over 2 months from the sNDA submission," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "With this label expansion, ZYNRELEF is now indicated in significantly more surgeries per year, enabling more institutions to consider therapeutic substitution for a broad range of surgical procedures. To make it easier for healthcare providers to use ZYNRELEF in patients having surgeries included in our newly expanded indications, reimbursement for ZYNRELEF outside the surgical bundle payment is now up to 120 million commercial and Medicaid covered lives in the ASC setting of care, which we believe will continue to grow over the next several quarters."
"As a surgeon, I have successfully used ZYNRELEF in over 200 total knee arthroplasty procedures and I have been very pleased with the results," said Alexander Sah, M.D., orthopedic surgeon at Sah Orthopaedic Associates. "With ZYNRELEF used as the foundation of a multimodal analgesic regimen, most of my patients experienced mild, very manageable pain following surgery and only a few have needed a small amount of opioids for the pain. I have been eagerly awaiting the FDA label expansion to begin using this medication in total hip arthroplasty and additional procedures to provide effective pain management for my patients."
Heron is continuing to study ZYNRELEF in additional procedures with plans to submit a second sNDA to the FDA in the second half of 2022 to support a broad indication for soft tissue and orthopedic surgical procedures, which is intended to cover the full 14 million target procedures.
12/09/2021
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