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# FDA Outlines Guidance on Combating Opioid Addiction
- URL: https://www.fdaweb.com/fda-outlines-guidance-on-combating-opioid-addiction/
- Published: 2018-04-20T12:00:00.000Z
- Updated: 2026-09-15T00:00:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141268

As part of its ongoing efforts to address the opioid epidemic, FDA 4/20 released a draft guidance to help sponsors develop medication-assisted treatments (MAT) and new formulations of existing drugs that could benefit patients suffering from addiction. The document, [“Opioid Dependence: Developing Buprenorphine Depot Products for Treatment,”](http://fda.pr-optout.com/Tracking.aspx?Data=HHL%3d8464A3-%3eLCE38%2b87%3e7-GLCE17.6&RE=MC&RI=4528954&Preview=False&DistributionActionID=81593&Action=Follow+Link&ref=fdaweb.com) outlines trial design issues for sustained-release depot buprenorphine products, which include modified-release products for injection or implantation. “Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse,” an [agency release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605248.htm?ref=fdaweb.com) says. “In particular, this draft guidance outlines possible ways companies can more efficiently explore innovations in buprenorphine products – from the data needed to support approval, to the specific review pathways that are available to help streamline how sponsors developing novel clinical endpoints that can form the basis of additional MAT product approvals.” 

A second guidance under development will provide a framework for the development of novel clinical endpoints that can form the basis of additional MAT product approvals. “For example, one endpoint that’s relevant to the treatment of addiction is the craving that fuels continued drug use,” the agency says, adding that it intends to support efforts to develop a validated measurement of “craving” or “urge to use” illicit opioids for use with other endpoints and to determine how it supports the goal of sustained abstinence.