Replace opioids!

Compilenewborn

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.

Zynrelef is said to be the first and only sustained-release dual-acting local anesthetic (DALA).

Heron plans to use Zynrelef as an alternative to opioid drugs for postoperative pain relief.

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.

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.

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.

Reference source: Heron's troubled opioid alternative for post-surgery pain takes flight with FDA nod