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Zynrelef Anesthetic Receives FDA Approval

Lifecore will manufacture the new innovative drug for treatment of postoperative pain.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Lifecore Biomedical Inc., a fully-owned subsidiary of Landec Corporation, has announced the receipt by Heron Therapeutics, one of Lifecore’s customers, of U.S. Food and Drug Administration (FDA) approval for its Zynrelef (formerly known as HTX-011) candidate on May 13, 2021, for which for Lifecore provides CDMO support.
 
Heron received FDA approval 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. 
 
Opioid-Free Pain Relief
 
Zynrelef, an 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 less pain, including severe pain, and fewer patients requiring opioids (opioid-free) after surgery as compared to bupivacaine solution, the current standard-of-care.
 
Dr. Albert Bolles, Landec’s chief executive officer, commented, “We congratulate Heron on their approval and are proud of Lifecore’s efforts in supporting the development of this innovative new opioid-free drug for overcoming postoperative pain. This is an excellent example of how Lifecore’s unique capabilities can help advance product commercialization for innovative drug therapies that improve patient lives.”
 
Jim Hall, president of Lifecore, continued, “We are excited about this approval and congratulate the Heron team on achieving this major regulatory milestone. The commercial scale manufacturing process of Zynrelef was successfully developed and validated at Lifecore and provides another example of Lifecore’s quality systems and manufacturing engineering excellence that we provide to our partners. We greatly appreciate Heron’s long-standing partnership and are pleased to be part of their ongoing commercial success.”
 
The approval of Zynrelef adds to Lifecore’s growing portfolio of partnerships and products, and further demonstrates Lifecore’s capabilities to support the development services and manufacturing of products that must comply with the stringent clinical and regulatory standards in the pharmaceutical marketplace. Lifecore says it is focused on continuing to work with its partners to develop, formulate and fill pharmaceutical drugs, medical devices and combination products.

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