www.fdanews.com/articles/202770-fda-approves-heron-therapeutics-zynrelef-for-postoperative-pain
FDA Approves Heron Therapeutics’ Zynrelef for Postoperative Pain
May 17, 2021
Heron Therapeutics’ Zynrelef (bupivacaine and meloxicam) has secured FDA approval as a postsurgical analgesic for up to 72 hours following knee replacements, abdominal hernia repairs and bunion removals.
The extended-release painkiller delivers the local anesthetic bupivacaine combined with a low dose of meloxicam, a nonsteroidal anti-inflammatory. In a phase 3 trial, the combination therapy resulted in less pain and fewer patients needing opioids postsurgery vs. bupivacaine alone, the current standard of care.
The San Diego, Calif.-based drugmaker plans to launch Zynrelef in July.