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# FDA Publishes 2 Analgesic Draft Guidances
- URL: https://www.fdaweb.com/fda-publishes-2-analgesic-draft-guidances/
- Published: 2026-05-13T12:00:00.000Z
- Updated: 2026-09-14T13:39:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161135

FDA has published draft guidances addressing the development of non-opioid analgesics and considerations for a benefit/risk assessment framework for opioid analgesics. The guidance on [developing non-opioid analgesics for chronic pain](https://www.fda.gov/media/128150/download?ref=fdaweb.com) addresses two FDA priorities — **(1)** fostering the development of novel analgesic products and **(2)** decreasing opioid analgesic exposure and preventing new addiction.

The document describes the agency’s current recommendations about Phase 3 trials for prescription non-opioid analgesic products being developed to treat chronic pain. It does not provide general recommendations on early phases of non-opioid analgesic drug development. It also does not have specific recommendations on pediatric drug development.

The second guidance, addressing a [benefit/risk framework for opioid analgesic drugs](https://www.fda.gov/media/188612/download?ref=fdaweb.com), summarizes the information that FDA recommends be included in an NDA for an opioid analgesic drug to facilitate FDA’s benefit/risk assessment and meet the standard for approval under section 505 of the Federal Food, Drug, and Cosmetic Act.