A study combining Heron Therapeutics Inc.'s non-opioid pain medication HTX-011 with common over-the-counter painkillers helped patients avoid opioids after undergoing foot surgery.
The San Diego-based biotechnology company examined HTX-011 in combination with acetaminophen and ibuprofen, compared to HTX-011-only, bupivacaine solution and placebo in patients undergoing bunionectomy surgery. In bunionectomy, an enlargement of bone and soft tissue at the base of the big toe is removed. The study is a follow up to a phase 3 clinical trial that similarly examined the drug's success in avoiding opioid use after bunionectomy with a different group of comparative treatments.
Heron noted that 77% of the patients who received HTX-011 with over-the-counter painkillers did not require opioids to manage their postoperative pain for 72 hours. Whereas 29%, 11% and 2% of the patients in the HTX-011-only, bupivacaine solution and placebo arms did not require opioids, respectively. The patients receiving the over-the-counter combination remained opioid-free through 28 days after surgery.
The company said the results from the follow-up study support the outcomes from a previous study in which 90% of hernia repair patients were opioid-free 72 hours after the surgery and 81% did not require opioids 28 days post-surgery.
The U.S. Food and Drug Administration granted a priority review to Heron's application for HTX-011 and will make a decision on the medicine by April 30.