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# After 2 Rejections, Heron Pain NDA Finally Approved
- URL: https://www.fdaweb.com/after-2-rejections-heron-pain-nda-finally-approved/
- Published: 2021-05-13T12:00:00.000Z
- Updated: 2026-09-14T16:58:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149317

FDA has approved a Heron Therapeutics NDA for 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. 

  
HTX-011is described as a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is said to be the first extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control.

  
The original NDA was filed in 2018 and received a complete response letter in 2019 based on the need for additional chemistry, manufacturing and controls and other non-clinical information ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5144000&searchWords=heron&cate=S&stid=%241%242E/.hr4.%24JfQpRwxrzp4Lh.N0HV4gF.&ref=fdaweb.com)). A second complete response letter was issued 6/2020 with FDA requesting more information to address four non-clinical issues, none of which relate to any observed toxicity, the [company said](https://ir.herontx.com/news-releases/news-release-details/heron-therapeutics-receives-complete-response-letter-htx-011-0?ref=fdaweb.com) at the time.