Heron Therapeutics Announces U.S. FDA Approval of ZYNRELEF? (HTX-011) for the Management of Postoperative Pain for up to 72 Hours

發(fā)布時(shí)間： 2021-05-17 閱讀：734次

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May 13, 2021 -- Heron Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (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.

"The approval of ZYNRELEF marks an exciting milestone for patients, healthcare providers and pain management. Not just because it can reduce postoperative pain for up to 72 hours, but because for many patients it can eliminate the need for opioids after surgery," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron.