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# FDA Planning 2 Guidances on Opioid Addiction
- URL: https://www.fdaweb.com/fda-planning-2-guidances-on-opioid-addiction/
- Published: 2018-02-26T12:00:00.000Z
- Updated: 2026-09-14T23:25:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140845

FDA is expected to release soon two new draft guidances intended to advance medication-assisted treatment (MAT) for opioid addiction. Speaking at the 2/24 National Governors Association annual meeting in Washington, DC, HHS secretary **Alex Azar** said one guidance will encourage more flexible and creative MAT study designs. “As just one example, the guidance will correct a misconception that patients must achieve total abstinence in order for MAT to be considered effective,” he said in his [prepared remarks](https://www.hhs.gov/about/leadership/secretary/speeches/2018-speeches/plenary-addres-to-national-governors-association.html?ref=fdaweb.com). “Researchers will be invited to develop new measures for evaluating the effects of MAT formulations — rather than just patterns of drug use. For instance, they might look at emergency-room visits or overdoses.”

The other guidance will address developing new formulations of buprenorphine that may be more effective for particular populations who are addicted. “As some of you may know, several months ago, FDA approved the first-ever monthly injection of buprenorphine, using what’s known as a ‘depot’ injection, a method that has long been used in psychiatric treatments,” he said. Depot injections make adherence easier — you only need a shot once a month, rather than going to get it every day... FDA’s guidance will help clarify what kind of evidence is needed to gain approval for new depot forms of buprenorphine, such as data regarding how quickly the drug is distributed in the bloodstream.”