Benzinga | Sep 28, 2020 08:35AM EDT

Heron Therapeutics Receives European Commission Authorization For ZYNRELEF For The Treatment Of Postoperative Pain

SAN DIEGO, Sept. 28, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the European Commission has granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency's (EMA) positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2020. Heron currently expects to make ZYNRELEF available to patients in the European Union (EU) during 2021.

ZYNRELEF is a non-opioid, dual-acting analgesic, utilizing a fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. For approximately 72 hours after ZYNRELEF is applied into the surgical site, ZYNRELEF releases bupivacaine and meloxicam, which are then absorbed into the surrounding tissues. Meloxicam potentiates the effect of bupivacaine, resulting in an increase in analgesia.

The European Commission's authorization of ZYNRELEF is based on the results of Heron's two multi-center, double-blind, active and placebo-controlled Phase 3 studies of ZYNRELEF. The primary endpoint and all 4 key secondary endpoints were met in both Phase 3 studies. ZYNRELEF demonstrated significantly reduced pain and opioid use through 72 hours compared to saline placebo and to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF also significantly increased the proportion of patients who required no postoperative opioids. The most common side effect with ZYNRELEF is dizziness.

The European Commission'scentralized marketing authorization is valid for the 27 countries that are members of the EU and the United Kingdom. Norway, Iceland and Liechtenstein will make corresponding decisions based on the decision of the European Commission.

"The authorization of ZYNRELEF in the EU is an important milestone for Heron, as well as for the millions of surgical patients in the EU for whom safety, pain relief and recovery are of primary importance," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "With a novel dual mechanism of action, and single, needle-free application, ZYNRELEF has been clinically shown to better manage severe pain than standard-of-care bupivacaine over 72 hours and we believe that ZYNRELEF adds an effective therapeutic option for the management of postoperative pain for eligible patients."