Heron Therapeutics Inc. said its experimental non-opioid pain medication HTX-011 in combination with over-the-counter painkillers helped patients with post-operative pain management after total knee replacement in a late-stage study.
A total knee replacement, or total knee arthroplasty, is a surgical procedure in which the diseased knee is replaced with artificial material, usually metal and plastic.
In the phase 3b study, the San Diego-based biotechnology company examined HTX-011 in combination with acetaminophen and celecoxib compared to placebo alone as well as liposomal bupivacaine in 51 patients undergoing total knee arthroplasty surgery.
Heron noted that 75% of the patients who received HTX-011 with over-the-counter painkillers were discharged from the hospital without a prescription for opioids. Patients reported mild pain through 72 hours post-surgery and the average consumption of opioids was four to five pills of oxycodone during that time. The HTX-011 combination was well-tolerated by the patients with no events of any serious side effects.
Previous studies have shown that HTX-011 helped patients avoid opioids and with postoperative pain management after undergoing hernia and foot surgeries.
Heron's HTX-011 is under review by the European Medicines Agency and on Oct. 1, the company refiled an application with the U.S. Food and Drug Administration seeking approval for HTX-011 following an initial rejection in April.
