Overview

• The draft outlines FDA expectations for phase 3 trials of prescription non-opioid analgesics intended for chronic pain.
• Stakeholders are invited to submit comments to the public docket by Nov. 10, 2025 to ensure consideration before finalization.
• The guidance addresses trial design, patient selection, endpoints, and use of patient-reported outcomes and statistical methods.
• FDA notes the goal of expanding effective alternatives to opioids and evaluating whether candidates can reduce opioid use.
• The document responds to Congress’s 2018 SUPPORT Act requirement to issue or update guidance that eases development of non-opioid pain therapies.