FDA Consults on Abuse-Deterrent CNS Stimulants
Posted 20 September 2019 | By
The US Food and Drug Administration (FDA) on Thursday opened a public consultation to gather input on the development and evaluation of abuse-deterrent formulations (ADF) of central nervous system (CNS) stimulants.
The agency also says it is seeking comments on whether such formulations could help to reduce prescription stimulant misuse and abuse.
According to FDA, most currently marketed prescription CNS stimulants are amphetamine salts and other similar compounds, such as methylphenidate, dextroamphetamine, dexmethylphenidate, methamphetamine and lisdexamfetamine and are used to treat attention deficit hyperactive disorder (ADHD) and narcolepsy.
"When used properly, prescription stimulants can provide significant benefits for patients. However, these drugs have a high potential for misuse and abuse," FDA writes, noting that the stimulants are classified as Schedule II drugs under the Controlled Substances Act
Amid the opioid epidemic, FDA and drugmakers looked to ADF opioids as a means of reducing the potential for misuse and abuse of those products. In many cases, drugmakers developed formulations with the intent of making it more difficult to abuse those formulations via specific routes of administration, such as injection or nasal inhalation.
The effectiveness of ADF opioids at mitigating abuse has been questioned. A 2017 report
from the Institute for Clinical and Economic Review (ICER) found there wasn't enough evidence to show that ADF opioids "are effective in reducing overall abuse at a population level" and warned that switching to ADF opioids may have "the unintended consequences of opioid users shifting abuse to other opioids or heroin, which may have ultimately resulted in increased harm."
FDA itself acknowledges that "postmarket data regarding the impact of ADF opioid analgesics in reducing abuse and associated adverse health outcomes, such as overdose, continues to be limited."
FDA says that in recent years it has heard from drugmakers looking to develop novel ADF CNS stimulants, though so far the agency has not approved any CNS stimulants with abuse-deterrent labeling.
While prescription opioid dispensing has declined slightly in recent years due to heightened awareness of abuse and misuse of those drugs, FDA says that prescription stimulant dispensing has increased from nearly 50 million prescriptions in 2012 to more than 60 million prescriptions in 2016.
FDA also says that the majority of individuals who misuse or abuse prescription stimulants "report doing so only occasionally, primarily to stay awake or enhance academic or work performance" and often do so while abusing or misusing other substances.
FDA notes that surveys suggest that most college students who misuse or abuse prescription stimulants take the pills orally, while a smaller report taking them intranasally. They agency says that injecting prescription stimulants seems to be uncommon among college students but points out that more "individuals being assessed for or entering substance abuse treatment" report taking prescription stimulants intranasally or injecting them.
"Both the patterns and magnitudes of misuse and abuse, morbidity, and mortality associated with prescription stimulants are quite different from those associated with prescription opioids," FDA writes.
For the consultation, FDA says it is looking for input and perspectives related to prescription stimulant misuse and abuse, including more data on the natural history of stimulant misuse and abuse and the risk of developing an addiction to such products.
FDA asks "whether ADF stimulants could be expected to meaningfully reduce prescription stimulant abuse and associated harms" and whether such formulations might benefit some patients.
Additionally, FDA says it is looking for input on how ADF stimulants should be studied in the pre- and postmarket settings and how abuse-deterrent properties should be described in labeling.