Use of the drug after surgery also significantly increased the proportion of patients who required no postoperative opioids. It was tolerated as well as placebo or bupivacaine. The positive opinion from CHMP, recommending the drug for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults, will be reviewed by the European Commission.
“Obtaining a positive opinion from the CHMP for ZYNRELEF is a major regulatory milestone and confirms the superiority of ZYNRELEF over bupivacaine solution, the current standard of care,” said Barry Quart, Pharm.D., president and chief executive officer of Heron. “We believe that the CHMP’s positive opinion of ZYNRELEF is an important step forward to help improve the lives of patients across the EU by significantly reducing the proportion of patients who experience severe pain after surgery.”
The company is currently awaiting decisions from the U.S. FDA and Health Canada after responding to questions from the regulatory bodies earlier this summer.
The conclusions of these studies aren’t necessarily surprising. In general, those who use opioids more before surgery will continue to do so after as well. But what is somewhat counterintuitive is that this is one of the few factors that actually predict long-term opioid use, more so than postoperative pain scores or invasiveness of the procedure.
In short, giving patients opioids leads patients to want or need more opioids. While more evidence will be helpful, it is fairly clear that there is much referring physicians and surgeons can already do to reduce opioid prescriptions through patient education, use of alternative pain-relief medication, and stopping the practice of sending everyone home with a prescription for an opioid drug.
