Heron Therapeutics, a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, 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.
ZYNRELEF 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.
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H.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.
“Submission of this sNDA is designed to further expand ZYNRELEF’s indication for use in soft tissue and orthopedic procedures, which would double the current target surgical procedures to 14 million. The combination of the existing CMS pass-through payments with the new legislation providing separate payments for ZYNRELEF in the outpatient setting of care through December 31, 2027 will provide for more than 4 years of separate reimbursement payments after the 10-month anticipated action date for this sNDA,” said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. “Expanding the indicated surgical procedures and gaining almost three additional years of separate payments from CMS is anticipated to significantly accelerate uptake of ZYNRELEF in large hospital systems, and allow many more patients to benefit from superior pain management over 72 hours with a reduced need for opioids.”
SOURCE: PR Newswire