FDA Significantly Expands Indication for Zynrelef Analgesia

The FDA significantly expanded the indication for Heron Therapeutics’ Zynrelef (bupivacaine and meloxicam) extended-release solution.

After FDA’s approval of the company’s supplemental new drug application (sNDA), Zynrelef is now indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures, Heron said in a news release.

The medication is the first and only therapy for postoperative pain management to be rigorously tested in phase 3 studies and demonstrate superiority to bupivacaine solution, the current standard-of-care, Heron said.

The expanded indication for Zynrelef will now cover around 7 million procedures annually.

Zynrelef demonstrated “superior, sustained postoperative pain relief for up to 72 hours and decreased the need for opioids, with more patients opioid-free compared to bupivacaine solution,” Heron said.

The use of the medication in the additional procedures offers surgeons the opportunity to further reduce their patients need for opioids following surgery, which can positively impact the patients and limit the postoperative discharge opioids that can lead to misuse, according to Heron.

“Postoperative opioids have been shown to be a doorway to addiction with over 2 million Americans becoming persistent opioid users after receiving opioids following surgery,” Heron said.

The highest number of overdose deaths on record occurred during the 12-month period ending April 2021, with over 100,000 American lives lost, according to the Centers for Disease Control.

The FDA approved the label expansion based on the strength of the Zynrelef clinical data in less than 6 months after its initial launch, Barry Quart, Pharm.D., chairman and CEO of Heron, said in a statement.

Quart also said that reimbursement for Zynrelef outside the surgical bundle payment is now up to 120 million commercial and Medicaid covered lives in the ASC setting of care, “which we believe will continue to grow over the next several quarters,” Quart said.

Heron is continuing to study Zynrelef in additional procedures and has plans to submit a second sNDA to the FDA in the second half of 2022 to support a broad indication for soft tissue and orthopedic surgical procedures, which is intended to cover the full 14 million target procedures.