Heron Therapeutics Announces Publication Showing ZYNRELEF® as the Foundation of a Perioperative Non-Opioid Multimodal Analgesic Regimen Reduced Severe Pain and Opioid Use in Patients Undergoing Total Knee Arthroplasty
The study was published in the
The use of ZYNRELEF 400mg/12mg in patients undergoing TKA with bupivacaine spinal anesthesia and scheduled MMA did not identify safety concerns, and there was no evidence of NSAID-related toxicity, suggesting that the MMA regimen did not impact the safety profile of ZYNRELEF.
"Total knee arthroplasty procedures have typically been associated with significant postoperative pain and high opioid requirements. The results presented in this study are promising for ZYNRELEF's ability to reduce severe pain and opioid consumption," said
"Postoperative pain is one of the main concerns we hear in the clinical setting, and as many orthopedic procedures continue to transition to the outpatient setting, it is becoming increasingly more important to manage pain effectively so patients can be ready for discharge the same day," said
In this single-arm study, patients undergoing unilateral TKA under spinal anesthesia received ZYNRELEF 400mg/12 mg instilled without a needle into the surgical space in conjunction with a non-opioid MMA regimen consisting of preoperative oral acetaminophen, celecoxib and pregabalin, and postoperative oral acetaminophen and celecoxib for 72 hours followed by oral acetaminophen and ibuprofen for 4 days. Patients were required to stay in the treatment facility to collect pain scores through the 72-hour time point following surgery. Rescue medications, including oral immediate-release oxycodone, IV morphine, and/or IV hydromorphone, were permitted on request.
ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution. 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.
ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which:
- can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID.
- cannot be used during heart bypass surgery.
- can increase the risk of gastrointestinal bleeding, ulcers, and tears.
ZYNRELEF should also not be used:
- if you are allergic to any components of ZYNRELEF, similar local anesthetics, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines.
- as a paracervical block, during childbirth.
The most common side effects of ZYNRELEF are constipation, vomiting, and headache.
The medicines in ZYNRELEF (a local anesthetic and an NSAID) may affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may have adverse effects on cartilage; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia).
Please see full Prescribing Information, including Boxed Warning.
ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic 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 anesthetic for postoperative pain control. 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
Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, the potential market opportunity for ZYNRELEF in the
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