US FDA Approves Heron Therapeutics’ Zynrelef Vial Access Needle

US FDA Approves Heron Therapeutics’ Zynrelef Vial Access Needle

By, Admin 27 September 2024

US FDA approves Heron Therapeutics prior approval supplement application for Zynrelef vial access needle

Overview

Heron Therapeutics, Inc., a commercial-stage biotechnology company, announced that the US Food and Drug Administration (FDA) has approved the company's Prior Approval Supplement Application for Zynrelef (bupivacaine and meloxicam) extended-release solution vial access needle (VAN).

Current vial access needle

  • The VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing Zynrelef's withdrawal time down to between twenty and forty-five seconds. 
  • The user-friendly ""container-like"" design of the VAN may enhance the safe use of Zynrelef, increase adoption, and improve the preparation process.

Statement from the CDO: Heron

  • With this approval, we are providing healthcare providers with a new mechanism that directly addresses one of Zynrelef's adoption hurdles and will help reduce preparation time for surgical staff,"" said Bill Forbes, PharmD, executive vice president, chief development officer at Heron. 
  • Reducing patients' pain during the first three days after surgery is critical for patient recovery and well-being following often painful procedures, and we anticipate the VAN will lead to increased Zynrelef adoption, positively impacting patient recovery.""

Statement from the CEO: Heron

  • The VAN approval, along with Zynrelef's January label expansion, its inclusion in the proposed 2025 Non-Opioid Policy for Pain Relief (NOPAIN Act), and the continued integration of our partnership with CrossLink Life Sciences, LLC (CrossLink), are all exciting milestones achieved during 2024 contributing to Zynrelef's continued progress,"" said Craig Collard, chief executive officer at Heron. 
  • We remain optimistic about the potential transformative impact the VAN will have, following its expected launch in Q4 2024, providing healthcare professionals with an easier to use, versatile, and effective solution for managing postoperative pain across a wide range of surgical procedures.

About Zynrelef

  • Zynrelef is the first and only dual-acting local anaesthetic that delivers a fixed-dose combination of the local anaesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. 
  • Zynrelef is the first and only extended-release local anaesthetic to demonstrate in phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anaesthetic for postoperative pain control. 

Zynrelef Approvals

  • Zynrelef was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. 
  • In December 2021, the FDA approved an expansion of Zynrelef's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. 
  • On January 23, 2024, the FDA approved Zynrelef for soft tissue and orthopaedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. 
  • Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

About the company: Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care.

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