The US Food and Drug Administration (FDA) has approved the first extended-release dual-acting local anesthetic of bupivacaine and meloxicam for pain management.
The approval was granted to Heron Therapeutics, Inc. for ZYNRELEF.
The dual-acting local anesthetic eliminated the need for opioids for up to 72 hours following surgery.
An extended-release solution, the treatment is for the use in adults for soft tissue or periarticular instillation. It produced post-surgical analgesia after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.
The drug provided a fixed-dose combination of local bupivacaine and a low dose of non-steroidal anti-inflammatory drug (NSAID) meloxicam.
A phase 3 study found the treatment superior to bupivacaine solution, with data showing sustained postoperative pain relief for 72 hours.
Investigators said the drug also resulted in a significant number of patients becoming opioid-free, compared to bupivacaine solution treatment.
The clinical studies included over 1000 patients. The most adverse effects following administration of ZYRNRELEF included constipation, vomiting, and headache.
In a statement, Barry Quart, PharmD, Chairman and Chief Executive Officer of Heron Therapeutics, said the approval of ZYRNRELEF “marks an exciting milestone” in pain management treatment.
“Not just because it can reduce postoperative pain for up to 72 hours, but because for many patients it can eliminate the need for opioids after surgery," Quart said.
Alan Rechter, MD, an orthopedic surgeon at Orthopedic Associates, LLP, went on to call the approval of ZYNRELEF a potential new path in reducing exposure to opioids in opioid-naïve patients.
“Through today's approval of ZYNRELEF, we now have a new therapy to offer patients, with the potential to meaningfully impact the postoperative pain management landscape and reduce, and even eliminate, unnecessary exposure to opioids in many patients," he concluded.
The drug is expected to be available in July 2021.