Heron Therapeutics announces FDA approval of Zynrelef for the management of postoperative pain for up to 72 hours
Heron Therapeutics, Inc. announced that the FDA has approved Zynrelef (bupivacaine and meloxicam) extended-release solution 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.
Zynrelef, the first and only extended-release dual-acting local anesthetic (DALA), delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam.
The synergy between bupivacaine and meloxicam in Zynrelef has resulted in patients experiencing significantly less pain, including severe pain, and significantly more patients requiring no opioids (opioid-free) after surgery as compared to bupivacaine solution, the current standard-of-care.
Zynrelef is the first and only therapy for postoperative pain management to be rigorously tested in Phase III 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. Clinical studies included over 1,000 patients, with the most common adverse reactions following Zynrelef administration being constipation, vomiting, and headache.