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Heron Therapeutics Announces Filing of an Efficacy Supplement for ZYNRELEF® and Provision in Newly Passed Congressional Bill Anticipated to Provide Separate Reimbursement Outside of the Packaged Surgical Payment for ZYNRELEF
- Supplemental New Drug Application Submitted Requesting Expansion of Indication to Broadly Cover Soft Tissue and Orthopedic Surgical Procedures - - Omnibus
About this update from Heron Therapeutics, Inc.
[{"type":"text","content":"- Supplemental New Drug Application Submitted Requesting Expansion of Indication to Broadly Cover Soft Tissue and Orthopedic Surgical Procedures -\n- Omnibus Spending Bill (H.R. 2617) Includes Provision to Provide Separate Payments for Non-Opioid Treatment for Pain Relief in the Outpatient Setting Beginning January 1, 2025 -\nSAN DIEGO, Dec. 29, 2022 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, today announced the submission of a supplemental New Drug Application (sNDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution to support the proposed indication for greatly expanded use of ZYNRELEF in soft tissue and orthopedic surgical procedures and a newly passed congressional bill that is anticipated to provide separate reimbursement outside of the packaged surgical payment for ZYNRELEF for almost 3 years.\nZYNRELEF is currently 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. The current sNDA is based on safety and pharmacokinetic data from recently completed clinical trials in total shoulder arthroplasty, spinal surgery, abdominoplasty, and C-section showing comparable results to the previously completed pivotal safety and efficacy trials of ZYNRELEF.\nH.R. 2617, the omnibus spending bill approved by Congress last week includes a provision (SEC. 4135. ACCESS TO NON-OPIOID TREATMENTS FOR PAIN RELIEF) requiring the Centers for Medicare and Medicaid Services (CMS) to pay for certain non-opioids outside the existing bundled payment for surgeries for the period of January 1, 2025 through December 31, 2027. In two Phase 3 trials, ZYNRELEF demonstrated the ability to significantly increase the proportion of patients taking no opioids after surgery and we believe it qualifies for this separate payment. ZYNRELEF currently has pass-through status in the outpatient setting of care through March 31, 2025 and this provision should extend separate reimbursement outside of the packaged surgical payment through December 31, 2027. \n\"Submission of this sNDA is design...