New Therapeutic May Revolutionize Pain Management
Tracey Romero • Mon, April 16th, 2018
With no end in sight for the opioid crisis in the U.S., a lot of attention is being paid to postoperative pain management strategies and finding a way to reduce the need for opioids to manage patients’ pain after surgery. To that end, Adynxx Inc., a clinical stage biotechnology company based in San Francisco, just released Phase 2 study data on a new therapeutic that may revolutionize pain management.
Investigational drug brivoligide when administered before surgery essentially inhibits transcription factor EGR1 (Early growth response protein 1) in neurons that regulate pain sensation, switching off the sequence of events that lead to exacerbated pain after surgery.
In this Phase 2 study, the researchers assessed the safety and efficacy of a single preoperative dose of brivoligide (AYX1) compared to placebo in 210 patients undergoing unilateral total knee arthroplasty. All the patients also received standard perioperative pain management.
Randomization into the study was stratified by a screening score of 20 or higher on the Pain Catastrophizing Scale (PCS) to balance out patients at higher risk for poor pain relief outcomes among the active and placebo groups.
According to the data, while the primary endpoint of reduction in pain with walking from day 7 to 28 was not met in the total study population, brivoligide did show a clinically significant reduction in pain and opioid use in those patients with higher PCS scores.
In these patients, the single preoperative dose of brivoligide reduced the time to achieve mild pain by 26 days, from 41 days in the placebo group, to 15 days in the brivoligide group.
Patients treated with brivoligide also used 37% less opioids compared to the placebo group and had a 30% reduction in pain at rest and a 25% reduction in pain with walking from day 7 to 28. This new therapeutic was also shown to have a good safety profile with no significant adverse events.
Donald C. Manning, M.D., Ph.D, chief medical officer of Adynxx explained to OTW that this is an important finding because patients with high PCS scores are the patient group that orthopedic surgeons have the greatest challenge with.
He said, “Postoperative pain management as it has evolved over the years adds more and more medication and nerve blocks and we haven’t had a great advance in postoperative care, especially for those with persistent pain. We are really just attacking the end product of all these genes that are turned on after trauma, so we thought it would be more efficient if we instead targeted the switch that turned them on. We have a therapy that is unlike anything that is out there.”
Adynxx hopes to begin recruiting patients for the Phase 3 clinical trial in patients with high PCS scores by the end of the year or the beginning of next year after their meeting with the Federal Drug Administration on the Phase 2 data.