Novel extended-release local anesthetic reduces both postoperative pain and opioid use

Managing postoperative pain requires physicians to strike a challenging balance between reducing pain through use of local anesthetics — which largely lose effectiveness beyond 24 hours — and prescribing longer-acting opioids, which expose patients to the risk of sliding into addiction.

During Becker's 28th Annual Meeting: The Business & Operation of ASCs, in a workshop sponsored by Heron Therapeutics, Alan Rechter, MD, an orthopedic surgeon at Orthopedic Associates in Houston, discussed a novel extended-release local anesthetic that helps manage postoperative pain for up to 72 hours while reducing the need for opioids.

Three key takeaways were:

  1. Conventional postoperative pain management suffers from an efficacy gap and a risk of opioid addiction. Post-surgical inflammation and pain are most severe in the 72 hours after surgery, yet local anesthetics rarely provide consistent pain relief beyond 12-24 hours.

    The usual solution for closing that gap is prescription of opioids, whose effects are longer-lasting, but which may cause addiction, with the associated human and healthcare-related costs that opioid addiction entails. Further, about 80 percent of filled opioid prescriptions remain unused and leftover medications linger in patients' homes, creating additional risk of accidental use by children or elderly members of the household, with potentially serious consequences.

  1. ZYNRELEF is an alternative to both short-acting anesthetics and opioids. The first and only extended-release dual acting local anesthetic (DALA), ZYNRELEF reduces postoperative pain from foot and ankle, small-to-medium open abdominal and lower extremity total joint arthroplasty surgical procedures. It is a novel, synergistic combination of bupivacaine and low-dose meloxicam, delivered in a proprietary Biochronomer® polymer for controlled diffusion over 72 hours and is administered via needle-free application that does not require mixing with bupivacaine to achieve efficacy.

    "We've had cases where ZYNRELEF completely eliminates the need for opioids after different surgeries. I've had total knee patients that took not one pain pill, which is just unheard of," Dr. Rechter said.

    In a series of Phase 2 and Phase 3 Heron Therapeutics clinical studies, ZYNRELEF was shown to be superior to extended-release bupivacaine or extended-release meloxicam given alone and superior to bupivacaine or placebo in terms of pain reduction over 72 hours. For example, patients in the EPOCH 1 bunionectomy study who were treated with ZYNRELEF experienced a 25 percent reduction in the consumption of opioids in the three days after surgery compared to patients who were administered bupivacaine and a 37 percent reduction compared to trial participants in the placebo arm. In addition, as many as 82 percent of patients treated with ZYNRELEF remained opioid-free through day 28 after surgery.

  1. ZYNRELEF's packaging, storage, availability and pricing provider customer value. With a shelf life of three years, storage at temperatures between 20-25 degrees Celsius, wide availability through authorized wholesalers and specialty distributors with applicable prime vendor discounts, GPO contracts and discounts, convenient packaging in two single-use vial sizes (14-mL and 7-mL, for different size of the surgical site), 340B and competitive pricing and separate reimbursement by Medicare and many commercial plans in the HOPD and ASC, expectations are that ZYNRELEF will usher in a new era of postoperative pain management.

    "We believe that ZYNRELEF may form the new foundation for post-op pain management," Dr. Rechter said.

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