FDA approves prior supplement application for Zynrelef vial access needle
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Key takeaways:
- Heron Therapeutics announced FDA approval of its prior approval supplement application for the Zynrelef vial access needle.
- The pain management solution is expected to launch in the fourth quarter of 2024.
Heron Therapeutics Inc. announced its prior approval supplement application for the Zynrelef extended-release solution vial access needle has been approved by the FDA, according to a company press release.
The Zynrelef vial access needle (VAN) is a postoperative pain management solution that delivers a fixed-dose, extended-release combination of bupivacaine and low-dose meloxicam, according to the release. The Zynrelef VAN is indicated for a variety of orthopedic surgeries, such as foot and ankle soft tissue procedures and lower extremity total joint arthroplasty.
“With this approval, we are providing health care providers with a new mechanism that directly addresses one of Zynrelef 's adoption hurdles and will help reduce preparation time for surgical staff,” Bill Forbes, PharmD, executive vice president and chief development officer at Heron Therapeutics, said in the release. “Reducing patients' pain during the first 3 days after surgery is critical for patient recovery and well-being following often painful procedures, and we anticipate the VAN will lead to increased Zynrelef adoption, positively impacting patient recovery.”
According to the release, the Zynrelef VAN is expected to launch in the fourth quarter of 2024.
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