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Heron Therapeutics Gets FDA Approval for ZYNRELEF VAN

Heron Therapeutics Gets FDA Approval for ZYNRELEF VAN

Heron Therapeutics, Inc. has announced that the US Food and Drug Administration (FDA) has approved the company's Prior Approval Supplement Application for ZYNRELEF (bupivacaine and meloxicam) extended-release solution VAN.

The VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF's withdrawal time down to between twenty and forty-five seconds. The user-friendly ‘container-like’ design of the VAN may enhance the safe use of ZYNRELEF, increase adoption, and improve the preparation process.

"With this approval, we are providing healthcare providers with a new mechanism that directly addresses one of ZYNRELEF's adoption hurdles and will help reduce preparation time for surgical staff," said Bill Forbes, PharmD, Executive Vice President, Chief Development Officer at Heron.

"Reducing patients' pain during the first three 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," Forbes added.

"The VAN approval, along with ZYNRELEF's January label expansion, its inclusion in the proposed 2025 Non-Opioid Policy for Pain Relief (NOPAIN Act), and the continued integration of our partnership with CrossLink Life Sciences, LLC (CrossLink), are all exciting milestones achieved during 2024 contributing to ZYNRELEF's continued progress," said Craig Collard, Chief Executive Officer at Heron.

"We remain optimistic about the potential transformative impact the VAN will have, following its expected launch in Q4 2024, providing healthcare professionals with an easier-to-use, versatile, and effective solution for managing postoperative pain across a wide range of surgical procedures," Collard added.

ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased the proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control.

ZYNRELEF was initially approved by the FDA in May 2021 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. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. 

More news about: drug discovery & development | Published by Aishwarya | September - 26 - 2024 | 217

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