Abuse-deterrent formulations (ADFs) help address unintentional misuse
The FDA has urged the development of opioids formulated specifically to encourage proper use1
- The FDA issued an updated Guidance for Industry in April 2015 to assist pharmaceutical companies in developing drug products with abuse-deterrent properties1
- Since 2010, several opioids with ADF technology have been approved by the FDA, and more are in development2
- It is important to understand the characteristics of these ADFs to help optimize chronic pain management2
Types of ADFs1
Categories of studies established to evaluate abuse potential1
- The FDA guidance describes 4 separate categories of studies for evaluating potential ADFs
- Categories 1 and 2 are most relevant to unintentional misuse
Laboratory manipulation and extraction studies (in vitro)
Pharmacokinetic (PK) studies (in vivo)
Clinical abuse potential/human abuse potential
As you know, opioids are not appropriate for all patients. But for those who are ideal candidates, education and practice of safe and proper use is essential for treatment success.
1. US Food and Drug Administration. Center for Drug Evaluation and Research (CDER). www.fda.gov/downloads/Drugs/Guidance-ComplianceRegulatoryInformation/Guidances/UCM377938.pdf. Accessed March 15, 2016.
2. Moorman-Li R, Motycka CA, Inge LD, Congdon JM, Hobson S, Pokropski B. A review of abuse deterrent opioids for chronic nonmalignant pain. P&T. 2012;37(7):412-418.