FDA Highlights ‘Proactive and Innovative’ Opioid Research

An FDA Clinical Pharmacology Corner online post highlights four recent articles demonstrating how the agency says it is using proactive and innovative regulatory research to tackle the nation’s opioid crisis. The post references two articles published in 12/2022 that discuss the agency’s collaborative and innovative research into the underlying biological and pharmacological pathways involved in respiratory depression due to opioids, prevention of possible overdose scenarios, and acceleration of fast-acting safe, and effective naloxone treatments.

The post also cites:

• an FDA Impact Story article describing the challenges in doing naloxone for the numerous prescription and illicit opioid compounds; and
• an FDA Spotlight on CDER article describing FDA’s multi-step approach to understanding if drugs other than benzodiazepines, which are co-administered with opioid drugs, might also raise the risk of respiratory depression.