November 20, 2018
ASA Weighs-in on Opioid Sparing Clinical Trials: FDA Advisory Committee Votes to Continue Discussions
Last week, the American Society of Anesthesiologists (ASA) encouraged a Food and Drug Administration (FDA) advisory committee to support clinical trials for surgical acute pain that focus on patients undergoing elective surgeries and measure outcomes by functional improvement in the patient and their quality of life.
ASA’s recommendations were made at a meeting of the Food and Drug Administration’s (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), which convened to discuss the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain. The Committee considered elements of trial design and endpoints of these studies and how to determine the clinical relevance of the results. ASA submitted its recommendations through formal comments to the docket and during the public session of the meeting.
Among its recommendations, ASA endorsed that clinical trials of acute surgical pain should:
- Examine utilization of non-opioids and multimodal approaches for postoperative pain management;
- Focus on preventing the transition of acute to chronic pain after surgery;
- Address adverse events related to opioid use in the perioperative period; and
- Study opioid induced hyperalgesia (OIH).
At the meeting, the AADPAC heard from industry representatives presenting on methodologies and outcomes, as well as from FDA clinical team leaders on the background and rationale for developing opioid sparing drugs, study designs and approved product labeling. Following the public comment session, the Committee discussed several clarifying questions and took a vote.
ASA’s representatives were particularly interested in questions related to defining a clinically meaningful decrease in opioid use to support an opioid-sparing claim; how much difference in analgesia (if any) would be permissible in a study of an opioid sparing drug, relative to the standard of care with an opioid; and considerations for study design to evaluate when a drug is intended to replace an opioid.
The Committee voted on two key questions and overwhelmingly concluded more information was necessary to vote ‘YES” on the following:
- Is any reduction in opioid use sufficient to warrant labeling as opioid sparing? If not, describe the criteria that would support such labeling.
- Is it sufficient to claim opioid-level analgesia for a novel analgesic based on the clinical trial population and without an opioid active comparator? If not, describe the type of comparisons that would provide support for a finding of opioid-level analgesia
Sharon Hertz, M.D., the Division Director of the Division on Anesthesia, Analgesia and Addiction Products at the FDA Office of Drug Evaluation, concluded the meeting with the acknowledgement that the FDA would continue to explore this issue in the future. ASA will continue to monitor this issue for future development.