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FDA Expands Medication-Assisted Treatment for Opioids

Agency moves to allow pharma companies to market more addiction-based medications

A PPM Brief

To further expand access to medication-assisted treatment (MAT) for opioid addiction, FDA plans to begin allowing pharmaceutical companies to sell medications that will help temper cravings, even if they do not fully end addiction, according to an article written in The New York Times.1 This message was indicated by US Health and Human Services Secretary Alex M. Azar II in remarks to the National Governors Association, who said that the agency is intending to “correct a misconception that patients must achieve total abstinence in order for MAT to be considered effective,” according to the piece.

Azar noted federal data that points to only one third of specialty substance abuse treatment programs offering MAT and said that he wants to raise that number, as well as reduce the stigma associated with addiction therapy.1 These sentiments are similar to those made by FDA Commissioner Dr. Scott Gottlieb, who has also promoted MAT programs while looking to reduce opioid prescriptions.2 Efforts are also reportedly being made to seek medications that help patients function better, and which can be used in combination with therapy or other social support, even if the medications do not completely halt addiction.1

“You could envision different MATs where the different treatments are addressing different aspects of what underlies the addiction, and helping people lead productive lives free from addiction to opioids,” one senior FDA official was quoted as saying in the article.

According to the article, FDA will soon publish two new guidance documents for pharmaceutical manufacturers on the issue of opioid treatment, which will:1

  • encourage the development of new, longer-acting formulations of existing drugs for opioid treatment
  • allow new drugs to be eligible for approval that do not end addiction but help with aspects of it, such as cravings or overdoses, with the goal of remaining complete abstinence.

Under the guidelines, patients and their families will have input as to how useful a particular drug may be. “We will permit an endpoint that shows substantial reductions but does not require the patient to be totally clean at every visit if the measurements are fairly frequent,” the senior FDA official said in the article.

Last updated on: January 3, 2019
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