FDA Continues to Promote New Treatments for Opioid Use Disorder

August 8, 2018

The U.S. Food and Drug Administration (FDA) issued a draft guidance Aug. 6 outlining new ways to measure and demonstrate the effectiveness and benefits of medication-assisted treatment (MAT).

A part of the FDA’s goal to increase development, access to, and adoption of MAT, the guidance aims to help the treatment of opioid use disorder (OUD) by spurring more innovation and development of MAT.

“Regular adherence to MAT helps patients gain control over their use of opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse,” the FDA said in the press release. “MAT, coupled with relevant social, medical and psychological services, is a highly effective treatment for OUD. Additionally, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration.”

The guidance encourages drug sponsors to consider the following new ways to evaluate MAT drugs:


Read the FDA press release.