FDA to fight opioid crisis with wider access to medication-assisted treatment

pharmafile | February 27, 2018 | News story | Manufacturing and Production, Medical Communications, Research and Development Alex Azar, FDA, medication-assisted treatment, opioid crisis, opioids, pharma 

The FDA is set to refocus its efforts in combating the United States’ opioid crisis. Speaking at a meeting of the National Governor’s Association on the weekend, Health and Human Services Secretary Alex Azar announced that the agency will soon release guidance to expand access to medication-assisted treatment (MAT), a combination of behavioural therapy and medication to reduce cravings and withdrawals from opioid use.

While MAT is recognised by many addiction specialists as the gold standard, the therapy has seen its share of detractors, including Azar’s predecessor Tom Price, who remarked: “If we’re just substituting one opioid for another, we’re not moving the dial much.”

“Medication-assisted treatment works. The evidence on this is voluminous and ever-growing,” Azar said, noting that the FDA also plans to issue guidance for studies designed to evaluate the effectiveness of MAT. “The guidance will correct a misconception that patients must achieve total abstinence in order for MAT to be considered effective,” he added.

Currently, only around one-third of addiction treatment programmes in the US offer the therapy, with Azar committing to ensuring it is more widely available to patients in the future.

While the FDA has approved a range of treatments for opioid use disorder including buprenorphine, methadone and naltrexone, the need for them to be consistently administered and adhered to in order to be effective presents a sizeable obstacle in offering effective treatment. As a solution, Azar revealed that the FDA would also be issuing guidance to encourage wider development of longer-acting formulations of existing therapies, pointing to the one-month injectable version of buprenorphine approved by the agency in November last year.

“Injections make adherence easier. You only need a shot once a month rather than going to get it every day,” he noted.  “But they also can be more feasible in rural settings, where the opioid crisis has hit especially hard and yet treatment options can be especially sparse.”

Matt Fellows

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