New postoperative pain relief drugs! The new non-opioid painkiller Zynrelef (Bubicain/Meloxicon) has been approved by THE EUROPEAN Union CHMP!

27, 2020 // Heron Therapeutics is a commercial biotechnology company focused on developing best-in-class drugs to meet some of the most important unmet medical needs., the company announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued a positive review recommending approval for Zynrelef (Bubicain/Meloxicon, formerly "HTX-011") for the management of postoperative pain, specifically for postoperative pain management of small and medium-sized surgical wounds in adults.now, CHMP's positive comments will now be reviewed by the European Commission (EC), which is expected to make a final review decision in September 2020.Zynrelef (HTX-011) is a non-opioid painkiller in the study, a dual-acting, fixed-dose combination of the local anaesthetic bupivacaine and the low-dose non-steroidal anti-inflammatory drug meloxicam, designed to treat pain and inflammation after a single dose at the surgical site.the drug is developed using Heron's proprietary Biochronomer drug delivery technology to provide superior pain relief by providing a sustained level of powerful anesthetics and local anti-inflammatory drugs directly to tissue damage sites, while reducing the need for systemic (systemic) pain drugs such as opioids, which pose harmful side effects, abuse, and addiction risks.note, the drug is the first and only long-acting, slow-release local anaesthetic: in Phase III studies, it has been shown to significantly reduce pain and opioid use in 72 hours compared to the current standard of care for postoperative pain control, the local anaesthetic bubbly solution.in the United States, the FDA issued a complete response letter (CRL) at the end of June for Zynrelef's New Drug Application (NDA) for the management of postoperative pain, which provides non-clinical information, no safety or efficacy issues, and no chemical, manufacturing and control (CMC) issues.previously, the FDA granted Zynrelef fast-track and breakthrough drugs.positive comments from ChMP on Bioonomer's drug delivery technology (Photo: Heron Therapeutics.both studies reached major endpoints and all four critical secondary endpoints.data show edified that Zynrelef showed significant reductions in pain and opioid use over a 72-hour time scale than the bubkas solution, the standard care anaesthetic currently used for postoperative pain control.Zynrelef significantly reduced pain intensity for 72 hours after surgery, significantly reduced postoperative opioid use, and significantly increased the proportion of patients who did not need opioids after surgery.in both studies, Zynrelef was generally well tolerated and its safety comparable to placebo and bubkain solutions. Barry Quart, President and CEO ofHeron, said: "While the positive review of Zynreef from CHMP is an important regulatory milestone, it recognizes Zynrelef's superiority over the Bubicain solution, which is currently a standard care option.we believe chMP's positive assessment of Zynrelef is an important step forward in helping to improve the lives of patients across the EU by significantly reducing the proportion of patients with severe postoperative pain. Professor Richard Langford, chief medical officer of St Pancras Clinical Research uk and chief consultant in pain medicine at the London Clinic, said: "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.CHMP recommended indications will enable surgeons to use the product in a wide range of operations, allowing patients to benefit from the long-term effects of this important product." () Original source: Heron Therapeutics Receives Positive CHMP Opinion for ZYNREFF (HTX-011) for the Management of Post of Pain.