FDA finalizes guidelines for drugmakers on opioid disorder treatments

The US Food and Drug Administration (FDA) has issued a final guidance, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment, which is intended to help companies develop drugs to treat the condition and addresses the clinical endpoints acceptable for demonstrating the effectiveness of drugs for the disorder.

This guidance includes minor changes to the draft document. It also builds on another final guidance issued by the FDA in February 2019 that outlines the agency’s current thinking about drug development and trial design issues relevant to the study of depot buprenorphine products. Sponsors are encouraged to discuss their plans with the agency early in the drug development process.

Clinical trials to evaluate the effectiveness of medications for the purposes of FDA approval have generally used changes in drug-taking behavior as an endpoint. This final guidance identifies several additional potential clinical endpoints and other outcome measures that drug developers may consider.