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Azar Backs New MATs for Opioid Addiction

— Soon-to-be released FDA guidance documents aim to help

MedpageToday

WASHINGTON -- Stigma is a barrier to crushing the opioid crisis, and strong leadership is needed to tackle it, said Alex Azar, JD, Secretary of Health and Human Services, speaking during the National Governors Association's winter meeting on Saturday, here.

Specifically, Azar noted that only one-third of treatment programs across the country provide medication-assisted treatment (MAT), and one reason is that such therapy is stigmatized.

Critics view it, in simplest terms, as replacing one drug with another.

Azar announced that the FDA would soon be releasing two new draft guidances intended to speed the development of new MATs.

In his talk, Azar likened withholding MAT for addiction to not offering antibiotics for an infection.

"Medication-assisted treatment works. The evidence on this is voluminous and ever growing," he said citing a study from Massachusetts that found MAT alongside social supports "reduced future chances of death by more than 50%."

It would be "impossible" to reverse the opioid epidemic without increasing the use of MAT, he said.

Currently, the three forms of FDA-approved therapies for treating opioid addiction are buprenorphine, naltrexone, and methadone, in conjunction with behavioral supports, according to the

Azar took on critics of these treatment options and praised those willing to pursue them: "Someone on medically assisted therapies, even one who requires long-term treatment, is not an addict. They need medicine to return to work, re-engage with their families, and regain the dignity that comes with being in control of their lives. These outcomes are literally the opposite of how we define addiction," he said.

"Our fellow citizens who commit to treatment should not be treated as pariahs; they are role models," Azar continued.

The two new guidances the FDA is set to release aim to improve the quality of MATs and access to such therapies across the country.

One guidance will help clarify the type of evidence that drug makers need to get FDA approval for new "depot" formulations of buprenorphine, "such as data regarding how quickly the drug is distributed in the blood stream."

Depot injections have only to be given once a month, compared with other forms of treatment that must be taken daily, and as a result can increase adherence.

The FDA approved the first monthly depot injections of buprenorphine several months ago, Azar noted.

The second guidance the FDA will be releasing includes a "more flexible and creative design" for MAT research studies.

"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.

"Researchers will be invited to develop new methods for evaluating the effects of MAT formulations rather than just patterns of drug use. For instance, they might look at [decreases in] emergency room visits or overdoses."

In addition to these upcoming guidances, Azar summarized the steps that HHS is already advancing through a five-part strategy that includes the following elements:

  • Better public health data
  • Improved research on pain and addiction
  • Promotion of evidence-based methods of pain management
  • Increased access to opioid overdose reversal drugs
  • Enhanced prevention, treatment, and recovery services

Regarding this last point, Azar highlighted the $10 billion that President Trump earmarked for the opioid epidemic and serious mental illness in his recent FY 2019 budget proposal, and noted that those funds would build on the $3 billion that he hopes will be in the FY 2018 omnibus appropriations bill in March.

In closing, Azar again stressed that leadership is critical in fighting stigma and viewing the opioid epidemic "not as a moral failing but as a moral challenge for every single American."

Between state governors and the White House, he said, "together we can recognize the challenge of opioid addiction for what it is and work to empower and heal our fellow citizens. "