FDA Approves New Drug Application to Expand Indication for Zynrelef

Credit: Heron Therapeutics, Inc

The FDA has approved Heron Therapeutics, Inc’s supplemental New Drug Application (NDA) to expand the indication of Zynrelef (bupivacaine and meloxicam) extended-release solution. The expanded indication for Zynrelef now includes soft tissue and orthopedic surgical procedures, including the foot and ankle, as well as procedures for which direct exposure to articular cartilage is avoided.

"The expanded indication is poised to have a transformative impact on patient care, providing healthcare professionals with a versatile and effective solution for managing postoperative pain across an even wider range of surgical procedures,” said Heron CEO Craig Collard, in a press release. “The new label expansion and recent partnership with CrossLink, combined with the potential approval of the Vial Access Needle later this year, are expected to have a significant positive impact for Zynrelef and the company.”

The FDA initially approved Zynrelef in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours following bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. The indication was expanded in December 2021 to include surgical procedures to the foot and ankle, small-to-medium open abdominal surgery, and lower extremity total joint arthroplasty.

Zynrelef contains the amide local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug meloxicam. It was the first and the only dual-acting local anesthetic approved by the FDA that provides a fixed-dose combination of these therapies.

According to Heron, the expanded indication now covers an estimated 13 million annual surgical procedures, which is an estimated increase of 86% over the drug’s previous indication.

"We're excited for the opportunity to give even more healthcare providers and patients a new, safe and effective option for achieving long-lasting non-opioid pain control after painful surgical procedures," said Bill Forbes, Heron executive vice president, chief development officer, said in a press release. "This new approval further reinforces our commitment to providing meaningful solutions to address unmet medical needs in the acute care and oncology settings."

The latest regulatory action was based on research for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. In Phase III studies, Zynrelef was the first extended-release local anesthetic to significantly lower pain and significantly increase the proportion of patients needing opioids through the first 72 hours after a surgical procedure compared to bupivacaine solution, which is the current standard-of-care local anesthetic for postoperative pain, according to Heron.

There were no new safety issues reported from the drug’s latest clinical trials, with bupivacaine and meloxicam blood concentrations consistent with prior findings with use of Zynrelef.

The most common adverse effects reported with Zynrelef in soft tissue procedures were vomiting and in orthopedic procedures were constipation and headache.

"Patients undergoing orthopedic procedures often experience severe pain, slowing down their recovery time and potentially leading to other complications. Reducing patients' pain within the first three days is critical for patient satisfaction, and having a product like Zynrelef now available for additional orthopedic procedures is a great benefit to have in my practice," said Alexander Sah, MD, orthopedic surgeon at Sah Orthopaedic Associates, in a press release. "Zynrelef helps my patients recover fully, be discharged sooner, and have significantly less pain, with little to no opioid use."

Reference

Heron Therapeutics Announces FDA Approval of ZYNRELEF® Indication Expansion to Include Additional Orthopedic and Soft Tissue Procedures. Heron Therapeutics. News release. January 23, 2024. Accessed January 25, 2024. https://ir.herontx.com/news-releases/news-release-details/heron-therapeutics-announces-fda-approval-zynrelefr-indication#:~:text=On%20January%2023%2C%202024%20%2C%20the,to%20articular%20cartilage%20is%20avoided.