The FDA has said it would publish two guidances, recommendations for drugmakers, on the issue of expanding medication-assisted therapy for individuals with opioid use disorder. One encourages the development of new, longer-acting formulations of existing drugs for opioid treatment. The other, which was described in detail to The Times, said new drugs would be eligible for approval that don’t end addiction but help with aspects of it, such as cravings, or overdoses, with the goal remaining complete abstinence.
“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,” a senior FDA official said.
The official also said the FDA was seeking medications that can help patients function better and can be helpful when used in combination with therapy and other social support, even if on their own the medications don’t completely end addiction. Under the new guidelines, patients and their families will have input in assessing how useful a drug is.
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