After several years of difficulties, the innovative product developed by Heron Therapeutics to replace opioids in the treatment of postoperative pain has finally won the nod of US regulators and will be launched in July this year.

On Thursday, the FDA approved Heron’s dual-acting anesthetic product Zynrelef, a sustained-release combination product composed of the local anesthetic drug bupivacaine and the anti-inflammatory drug meloxicam. The specific indications are: as a postoperative analgesic drug for adult patients undergoing total knee replacement, bunion resection, and inguinal hernia repair, providing up to 72 hours of analgesia.

Zynrelef is said to be the first and only sustained-release dual-acting local anesthetic (DALA). Within 72 hours after surgery, patients will experience the most severe postoperative pain and are most likely to receive opioids to control their pain. In clinical trials, a single dose of Zynrelef can significantly reduce pain and reduce opioid use 72 hours (3 days) after surgery.

Heron plans to use Zynrelef as an alternative to opioid drugs for postoperative pain relief. The drug is very simple to use, just drop it directly on the surgical site before suturing. The Phase 3 clinical trial approved by Zynrelef showed that when used for postoperative pain management, Zynrelef showed better postoperative pain relief than the standard care plan local anesthetic bupivacaine solution, which not only reduced postoperative patients The demand for opioids, and more patients do not need opioids at all.

Previously, after recognizing the serious demand for non-opioid drugs, the US FDA granted Zynrelef Fast Track Designation (FTD) at the end of 2017, and awarded the drug Breakthrough Drug Designation (BTD) in the second quarter of 2018.

But Zynrelef's road to the regulatory finish line is not without obstacles. In May 2019, Heron stated that it had received a complete response letter (CRL) from the FDA for Zynrelef's New Drug Application (NDA) requesting additional chemical manufacturing and control (CMC) information.

The company’s CEO Barry Quart said at the time that he was “very disappointed” that these issues were not resolved during the drug’s six-month priority review period, and added that the company would seek to meet with the FDA to resubmit the NDA as soon as possible. .

In June 2020, Heron suffered another setback, receiving a second CRL related to 4 non-clinical issues.

Now, Heron expects Zynrelef to be available on the US market in the early summer of this year. Zynrelef is already on the market in Europe. The drug was approved by the European Commission in September 2020 for the treatment of postoperative body pain from small and medium surgical wounds in adults.

Investment bank Jefferies analysts previously estimated that if Zynrelef is approved for specific indications and can declare on its label that its efficacy is better than conventional bupivacaine, its peak sales will reach 545 million US dollars.