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FDA Seeks Comments on Abuse-Deterrent Formulations of Stimulants

October 18, 2019

The US Food and Drug Administration announced it is receiving public comments on “considerations related to the development and evaluation of abuse-deterrent formulations (ADF) of central nervous system stimulants and whether such products could play a role in addressing public health concerns related to prescription stimulant misuse.”

Patients and their advocates, healthcare professionals, academics and researchers, the pharmaceutical industry and other government entities are invited to submit a formal comment. The comment period closes Nov. 19.

To date, the FDA has approved several abuse-deterrent formulations of opioid analgesic products, but the agency has not approved similar labeling for any prescription stimulants.

The FDA’s notice provides an overview of available data on use, misuse and abuse of prescription stimulants and associated morbidity and mortality, as well as similar data for prescription opioids for context. It also includes background information on the development and evaluation of abuse-deterrent formulation products and a series of questions for which the FDA specifically seeks input.

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