One new measure will be considering for FDA approval drugs that do not “cure” addiction, but help relieve symptoms such as cravings, Health and Human Services Secretary Alex M. Azar II said in a speech to the National Governors Association.
The FDA also wants to encourage drugmakers to develop new, longer acting formulation of existing MAT drugs, which include buprenorphine (often known by the brand name Suboxone), methadone and naltrexone (known by the brand name Vivitrol), the New York Times reported.
Azar said the FDA wants to “to correct a misconception that patients must achieve total abstinence in order for MAT to be considered effective.” One senior FDA official told the Times that “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.
“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 FDA official said. He also indicated that the agency wants to gather input from patients and their families when evaluating the efficacy of new addiction drugs.
“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, even in situations where they still might require replacement therapy,” the official told the Times.
One treatment executive interviewed by the Times said the FDA needs to remain scientifically rigorous in assessing any new drugs. “The FDA should keep companies focused on major clinical improvement for patients,” said Yngvild Olsen, medical director of the Institutes for Behavior Resources in Baltimore.
“A more thoughtful approach to measuring meaningful clinical improvement could expand treatment options, but there is a danger; subjective outcomes that are neither here nor there could encourage the development of products of questionable value.”
Andrew Kolodny, M.D. a director of opioid policy research at Brandeis University, said that the biggest hurdle to successful treatment of opiate addicts is not a lack of effective medications, but limited access. “We already have an effective treatment that people aren’t getting access to,” he said. “The primary challenge is getting it to people.”
Citing federal data showing that only one-third of specialty substance abuse treatment programs offer medication-assisted treatment, Azar said, “We want to raise that number — in fact, it will be nigh impossible to turn the tide on this epidemic without doing so.”
Medication-assisted treatment works,” Azar said in prepared remarks for a session of the National Governors Association’s winter meeting that were shared with The Hill.com. “The evidence on this is voluminous and ever growing.”
He said failing to offer medication-assisted treatment is “like trying to treat an infection without antibiotics. Under this administration, we want to raise that one-third number—in fact, it will be nigh impossible to turn the tide on this epidemic without doing so,” Azar said.