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  1. FDA In Brief

FDA In Brief: FDA seeks input on development and evaluation of abuse-deterrent formulations of central nervous system stimulants

September 19, 2019

Media Inquiries

  Sandy Walsh
  301-796-4669

“Prescription central nervous system stimulants are medicines that are used for the treatment of attention deficit hyperactivity disorder and, in some cases, narcolepsy. When used appropriately, prescription stimulants can provide significant benefits for patients. However, these drugs can also be abused, and the FDA recognizes this is an important public health concern,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Drug developers have started work on novel formulations of prescription stimulants with properties intended to deter abuse. Given the importance of these drugs and to make certain we have all the needed information to guide this work, the FDA feels it will be beneficial to open a public discussion about considerations related to the development of such products and the impact they could have. The FDA is interested in public input on whether and to what extent abuse-deterrent formulations of prescription stimulants might reduce abuse and wants to explore the potential public health impact of any such reduction. To start this conversation, today we’ve issued a request for comment to gain input and insight into these issues.”

Today, the U.S. Food and Drug Administration issued a Federal Register notice to establish a public docket to receive comments from interested parties, including patients, patient advocates, health care professionals, academics, researchers, the pharmaceutical industry and other government entities 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 and abuse.

Although the FDA has approved multiple ADF opioid analgesic products with language in the drug labeling stating that these products are expected to deter abuse via specific routes of administration, the agency has not approved similar labeling for any prescription stimulants. While comparisons may be made between ADFs of opioids and stimulants, in the case of opioid pain medications, the scope of misuse and abuse, illness (morbidity), and death (mortality) is different for prescription opioids than for prescription stimulants.

The notice provides an overview of available postmarket data on the use, misuse, and abuse of prescription stimulants and associated harms, with data on opioid analgesics provided for context. It also provides background information on the development and evaluation of ADF products and questions for which the FDA is seeking input. Specifically, the agency is requesting comment on new or additional information and perspectives on prescription stimulant misuse and abuse and associated harms and unintended consequences, including the risk of developing addiction and risk of transitioning to abuse of illicit stimulants or other substances.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.