Heron Therapeutics receives FDA approval for Zynrelef
Heron Therapeutics Inc. announced it received FDA approval for Zynrelef to provide postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
An extended-release dual-acting local anesthetic that delivers a fixed-dose combination of bupivacaine and low-dose meloxicam, Zynrelef demonstrated superiority to bupivacaine for postoperative pain management in phase 3 studies, according to a company press release. The release noted patients who received Zynrelef experienced significantly less pain for up to 72 hours postoperatively and required significantly fewer opioids after surgery compared with patients who received bupivacaine.
“The approval of Zynrelef marks an exciting milestone for patients, health care providers and pain management. 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,” Barry Quart, PharmD, chair and CEO of Heron, said in the release. “We are in a strong position to launch Zynrelef, given our highly successful hospital launch of Cinvanti and our pricing and unprecedented value proposition, which will ensure broad access for patients and health care providers. Our existing commercial team will immediately begin working with current accounts to gain formulary access, with full commercial availability expected by July 2021.”