FDA approves expansion for ZYNRELEF
pharmafile | December 10, 2021 | News story | Medical Communications |
The FDA has approved Heron Therapeutics’ supplemental New Drug Application (sNDA) for ZYNRELEF (bupivacaine and meloxicam), to significantly expand the indication.
ZYNRELEF is 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 Therapeutics is a commercial-stage biotechnology company, focused on developing treatments to address unmet patient needs. ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase III studies, and demonstrate superiorit to bupivacaine solution, which is the current standard-of-care.
The expanded indication for ZYNRELEF will now cover approximately seven million procedures annually. Through use of this drug, surgeons can also further reduce their patients’ need for opioids following surgery, diminishing the chances of misuse with postoperative discharge opioids, which can often lead to addiction.
“The FDA approved the label expansion based on the strength of the ZYNRELEF clinical data in less than 6 months after our successful initial launch and only a little over 2 months from the sNDA submission,” said Barry Quart, Pharm D, Chairman and CEO of Heron.
“With this label expansion, ZYNRELEF is now indicated in significantly more surgeries per year, enabling more institutions to consider therapeutic substitution for a broad range of surgical procedures. To make it easier for healthcare providers to use ZYNRELEF in patients having surgeries included in our newly expanded indications, 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.”
Lina Adams
