Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. This guidance is intended to assist sponsors in developing drugs for medication-assisted treatment of opioid use disorder (OUD). This guidance addresses the clinical endpoints acceptable to demonstrate effectiveness of such drugs.

The full draft can be viewed below.