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Heron Therapeutics Announces FDA Approval of a Significant Indication Expansion for ZYNRELEF®
- Approval provides a significantly broader indication for ZYNRELEF, now covering approximately 7 million procedures a year - - Conference call and webcast
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"- Approval provides a significantly broader indication for ZYNRELEF, now covering approximately 7 million procedures a year -\n - Conference call and webcast today, December 9, 2021 at 8:30 a.m. ET -\n\n\nSAN DIEGO, Dec. 9, 2021 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), 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. \nZYNRELEF 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. \nThis 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. \n\"The FDA approved the label expansion based on the strength of the ZYNRELEF clinical data in less than...