FDA Encourages Development of New Treatments for Opioid Use Disorder

The Food and Drug Administration (FDA) issued new scientific recommendations this week designed to encourage development of new medication-assisted treatment drugs for opioid use disorder.

The recommendations outline new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing medication-assisted treatment products, Modern Healthcare reports.

The new guidelines allow drug developers to look beyond whether the treatments reduce opioid use. They can show the treatments’ effectiveness through reductions in death rates, emergency department visits or transmission of hepatitis C. Other outcomes could include improvements in patients’ ability to resume school or work, or the percentage of patients with moderate to severe opioid use disorders who go into remission while using the treatments.

“As we seek to help those with an opioid use disorder transition to lives of sobriety, we recognize there’s great interest in new treatment options that result in meaningful outcomes for patients,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission.”