Abuse-deterrent properties do not prevent or reduce the risk of addiction1
Study categories that describe potential abuse-deterrent properties
FDA encourages research that will advance the development and assessment of abuse-deterrent technologies2
- Development of opioids with abuse-deterrent properties is considered a public health priority
- FDA believes it is critical to address the problem of opioid abuse while seeking to ensure that patients in pain have appropriate access to opioid therapies
- FDA guidance outlines 4 categories of studies that may be performed when evaluating the abuse-deterrent characteristics of an opioid therapy
The goal of FDA-approved product labeling for abuse-deterrent opioid formulations2
Abuse-deterrent product labeling should:
- Reflect the available data regarding the formulation's expected or known impact on abuse, based on the results of studies performed on the formulation
- Accurately convey any uncertainty regarding the impact of abuse
Category 1
Laboratory-based in vitro manipulation and extraction studies
Evaluate the ease with which the potentially abuse-deterrent properties of a formulation can be defeated or compromised.
Category 2
Pharmacokinetic studies
Evaluate the in vivo properties of the formulation by comparing the pharmacokinetic profiles of the manipulated formulation with the intact formulation and with manipulated and intact formulations of the comparator drugs through one or more routes of administration.
Category 3
Clinical abuse potential studies
Assess the impact of potentially abuse-deterrent properties in vivo, generally conducted in a drug-experienced, recreational user population.
Category 4
Postmarket studies
Determine whether the marketing of a product with abuse-deterrent properties results in meaningful reductions in abuse, misuse and related adverse clinical outcomes, including addictions, overdose and death in the post-approval setting.
Additional risks specific to abuse of Hysingla ER
- Hysingla ER is for oral use only. Abuse of Hysingla ER poses a risk of overdose and death. Abuse may occur by taking intact tablets in quantities greater than prescribed or without legitimate purpose, by crushing and chewing or snorting the crushed formulation, or by injecting a solution made from the crushed formulation. The risk is increased with concurrent use of Hysingla ER with alcohol or other central nervous system depressants. Taking cut, broken, chewed, crushed, or dissolved Hysingla ER increases the risk of overdose and death
- Hysingla ER contains hydrocodone, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Hysingla ER can be abused and is subject to misuse, addiction, and criminal diversion
