FDA Publishes 2 Analgesic Draft Guidances

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 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, 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.