In an effort to further combat the opioid crisis, the Food and Drug Administration (FDA) has issued draft guidance addressing the development of novel analgesic drugs that have the potential to decrease opioid use and prevent addiction.
In the draft guidance, the FDA defines acute pain as pain, lasting up to 30 days, typically in response to some form of tissue injury, such as trauma or surgery. According to the Agency, clinical trials that support a finding of efficacy for a nonopioid analgesic for the management of acute pain should be randomized, double-blind, superiority studies with an assessment of pain intensity as the primary outcome measure.
Additionally, the labeling should include data indicating that use of the product would either eliminate or reduce patient exposure to opioid analgesics. Nonopioid analgesic development programs that are designed to replace or reduce opioid analgesic use may also be eligible for expedited review under 1 or more of the FDA’s expedited programs.
“Preventing new addiction through fostering the development of novel nonopioid analgesics is an important priority for the FDA,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “The guidance reinforces the Agency’s commitment to confront opioid misuse, abuse and addiction by taking steps to help those with acute pain get access to improved nonopioid treatment alternatives.”
Prior to issuing final guidance documents, the FDA will be accepting public comments on the draft guidance until April 11, 2022.
FDA takes steps aimed at fostering development of non-addictive alternatives to opioids for acute pain management. News release. US Food and Drug Administration. Accessed February 9, 2022. https://www.prnewswire.com/news-releases/fda-takes-steps-aimed-at-fostering-development-of-non-addictive-alternatives-to-opioids-for-acute-pain-management-301478846.html