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FDA Suggests New Ways to Measure Efficacy of Opioid Addiction Treatment Drugs

August 8, 2018

On Monday, the Food and Drug Administration (FDA) issued draft guidance that offers drug developers new ways to measure the efficacy of medication-assisted treatments for opioid use disorder (OUD).

Pivotal trials of new medications for OUD have generally used reduction in drug-taking behavior as a primary efficacy endpoint. The new draft guidance recommends use of other endpoints to measure efficacy including:

  • Reductions in OUD-related mortality, emergency department visits, overdose, and transmission of the hepatitis C virus.
  • Proportion of patients that transition from meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) criteria for moderate to severe OUD at baseline to DSM-5 criteria for OUD remission at the end of the trial.
  • Improvements in patient-reported ability to resume work, school, or other productive activity.

The draft guidance does not recommend retention in treatment as a stand-alone endpoint.

The U.S. Substance Abuse and Mental Health Services Administration recently reported that only 20% of the 2.1 million Americans with OUD receive addiction treatment.


Food and Drug Administration (FDA). FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder [news release]. August 6, 2018. Available at: click here. Accessed August 7, 2018.