The FDA today released draft guidance for developers of devices meant to treat opioid-use disorder.
The agency cited the specific challenges of designing clinical studies to evaluate these devices, including inaccurate self-reporting of drug use, missing data, the confounding effects of related drug treatments and the lengthy observation periods needed to demonstrate therapeutic.durability.
For example, the FDA said pivotal device studies to support marketing submissions “should have a well-defined study population, appropriately monitor drug use, control for bias and include an appropriate follow-up period, study participant retention plans and data analysis plans.”
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The FDA wants feedback on the draft guidance to review before finalization. The agency said the guidance doesn’t apply to diagnostics for opioid use or opioid use disorder, combination products, or devices intended to treat pain.
“We are committed to helping industry develop solutions that are proven to be effective to address the devastation caused by the overdose crisis,” FDA Commissioner Dr. Robert Califf said in a statement. “This draft guidance for device studies should prompt industry to collect more comprehensive, timely and diverse data to support device submissions that may help improve the lives of those with opioid use disorder. These and similar efforts will continue to advance within the agency, with the input from industry, stakeholders and, most importantly, those managing opioid use disorder.”
The agency said the draft guidance advances evidence-based treatment for substance-use disorders, one of the goals of the Overdose Prevention Framework.
“Promoting device innovation to assist in the treatment of individuals with opioid use disorder is vital to our ongoing public health response,” FDA Center for Devices and Radiological Health Director Dr. Jeff Shuren said in a statement. “This guidance supports innovative approaches for evaluating medical devices that can help combat this national crisis and give patients new tools to treat opioid use disorder, with the assurance that the solutions we need will be driven by robust data.”