FDA Will Promote Suboxone and Other Medicated-Assisted Treatments

Research shows that overdose survivors who started using methadone or buprenorphine were half as likely to die of a subsequent overdose than those who did not turn to MAT.

The Food and Drug Administration (FDA) is aiming to promote the use of medication-assisted treatments (MAT) for opioid addiction, the federal agency’s commissioner told a congressional committee last week.

Scott Gottlieb, who heads up the FDA, called out MAT skeptics, saying that potentially life-saving treatments should not be stigmatized.

“This attitude reveals a flawed interpretation of science,” he told the House Energy and Commerce Committee, according to Bloomberg. “It stems from a key misunderstanding that many of us have of the difference between a physical dependence and an addiction.”

The FDA is also weighing whether to change medication labels, both to permit them for use in anyone who overdoses and to note that patients may require life-long treatment.

The agency will also put out guidance for MAT—which can include treatments like Suboxone, methadone and naltrexone—with the goal of promoting their use and battling stigma sometimes associated with the medications.

“There’s a wealth of information supporting the use of these medications,” Gottlieb said, according to STAT News.

“We’re focusing on the data in the drug labeling that can help drive broader and appropriate prescribing. So one concept that FDA is actively pursuing is the research necessary to support a label indication for medication-assisted treatment for everyone who presents with an overdose, based on data showing a reduction in death at a broader population-level. Such an effort would be a first for FDA.”

Recently, health officials in Massachusetts found that overdose survivors who started using methadone or buprenorphine were half as likely to die of a subsequent overdose, as compared to overdose survivors who did not turn to MAT.

A push for medication-assisted treatment was one of a number of recommendations that came out of the White House opioid commission’s interim report last summer. And earlier this year, the FDA sought to fight the battle against opioids taking a different approach, when officials asked Endo International to stop selling the painkiller Opana ER.

In 2016, more than 64,000 people in the U.S. died from opioid overdoses, including everything from heroin to fentanyl to OxyContin, according to data from the National Institute on Drug Abuse.