The European Union has approved Zynrelef, a new non-opioid dual-acting painkiller

Heron Therapeutics is a commercial biotech company focused on developing best-in-class drugs to meet some of the most important unfolested medical needs. Recently, the company announced that the European Commission (EC) has approved Zynrelef (formerly known as HTX-011, Bubikain/Meloxicon) for the treatment of postoperative pain caused by small and medium-sized surgical wounds in adults. Heron expects Zynrelef to be launched in the EU market in 2021.Zynrelef (HTX-011) is a new, non-opioid painkiller, a dual-acting, fixed-dose combination of local anaesthetic bubicaine and low-dose nonsteroidal anti-inflammatory drug meloxicam, designed to treat pain and inflammation after a single dose at the surgical site.Developed using Heron's proprietary Biochronomer drug delivery technology, the drug provides superior pain relief by providing consistent levels of powerful anesthetics and topical anti-inflammatory drugs directly to tissue damage sites, while reducing the need for systematic (systemic) medications such as opioids, which have harmful side effects, abuse and addiction risks.It is worth mentioning that Zynrelef is the first long-acting, slow-release local anaesthetic: in Phase III studies, it has been shown to significantly reduce pain and opioid use within 72 hours compared to the current standard local anaesthetic Bubikain solution for postoperative pain control.In the U.S., the FDA issued a full response letter (CRL) at the end of June to Zynrelef's new drug application (NDA) for the management of postoperative pain, covering non-clinical information, finding no safety or ability issues, and no chemical, manufacturing, and control (CMC) issues. Previously, the FDA granted Zynrelef fast-track and breakthrough drug eligibility.Zynrelef was approved by the European Union based on the results of two Phase III clinical studies. Both studies reached the main endpoint and all four key secondary endpoints. The data showed that Zynrelef showed a significant reduction in pain and opioid use within 72 hours compared to Bubikain solution, the standard care anaesthetic currently used for postoperative pain control, in postoperative pain control. Zynrelef significantly reduced the intensity of pain 72 hours after surgery, significantly reduced the use of postoperative opioids, and significantly increased the proportion of patients who did not need opioids after surgery. In both studies, Zynrelef was generally well-to-do, and its safety was comparable to that of placebo and bubicain solutions.Managing postoperative pain remains a major challenge for many doctors, as 80 per cent of patients across Europe experience moderate to severe pain within days of surgery. Postoperative pain can lead to pain, longer hospital stays, and higher medical costs. Clinical data show that Zynrelef is very effective in postoperative pain management. This approval will enable surgeons to use the product in a wide range of operations, enabling a wide range of patients to benefit from the long-lasting effects of this important product.Barry Quart, President and CEO of Heron, said: "Zynrelef's approval in the EU is an important milestone for Heron and millions of surgical patients in Europe. Zynrelef has a novel dual mechanism of action and single, needle-free application, clinically proven that Zynrelef can treat severe pain better within 72 hours than the standard care drug Bubicain, and we believe Zynrelef will add an effective treatment option for the management of postoperative pain in eligible patients. (Bio Valley)original origin: Heron's Zynrelef OK'd in Europe for post-op pain