FDA Issues Recommendations To Encourage Development Of Opioid Use Disorder Treatment Medications

On August 6, 2018, the U.S. Food and Drug Administration (FDA) issued new scientific recommendations to drug sponsors to encourage medication assisted treatment (MAT) drug development for the treatment of opioid use disorder (OUD). The recommendations promote both creation and improvement of these drugs by suggesting new methods of measuring and demonstrating the effectiveness and benefits of new or existing MAT products.

The recommendations were released in "Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry," by the FDA's Center for Drug Evaluation and Research (CDER). The recommendations note that the . . .