The FDA announced steps to help facilitate innovation in devices intended to treat opioid use disorder (OUD). The draft guidance, to help sponsors design clinical studies to evaluate these devices, furthers the FDA’s Overdose Prevention Framework goal of advancing evidence-based treatment for those with substance use disorders.
The draft guidance, Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder, outlines key considerations intended to aid sponsors in designing clinical studies for devices intended to treat OUD that address some of the complex challenges associated with these studies, including inaccurate participant reports of drug use, high rates of missing data, the confounding effects of concomitant drug treatments and the need to demonstrate the durability of the treatment effect of the device, which can necessitate prolonged observation. In particular, the draft guidance recommends that pivotal OUD device studies to support marketing submissions should have a well-defined study population, appropriately monitor drug use,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. By addressing these challenges early in the development of their clinical studies, sponsors should be well-positioned to obtain the most useful data to provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD.
The draft guidance provides industry critical recommendations toward efforts to bring safe and effective devices intended to treat OUD to market and provide more tools to reduce the harms that opioid use disorder causes patients, families and communities. It also provides recommendations that may be applicable to other types of studies intended to generate valid scientific evidence that may be used in providing a reasonable assurance of safety and effectiveness. Stakeholders can share feedback on the draft guidance, which the FDA will review before it is finalized.
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