OxyContin® was reformulated and in 2013 FDA approved labeling describing abuse-deterrent properties1-3
Formulated with inactive ingredients intended to:
- Make the tablet more difficult to manipulate for misuse and abuse
- In vitro data demonstrate that OxyContin has physicochemical properties expected to make abuse via injection difficult
- Data from a clinical study, along with support from the in vitro data indicate that OxyContin has physicochemical properties that are expected to reduce abuse via the intranasal route
- Abuse-deterrent properties do not prevent or reduce the risk of addiction4
- Abuse of OxyContin by injection and intranasal routes, as well as by the oral route, is still possible
- All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use
- With parenteral abuse, the inactive ingredients in OxyContin can be expected to result in local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, valvular heart injury, embolism, and death. Cases of thrombotic microangiopathy (a condition characterized clinically by thrombocytopenia and microangiopathic hemolytic anemia) associated with parenteral abuse have been reported. Parenteral drug abuse is commonly associated with transmission of infectious diseases, such as hepatitis and HIV
The goal of FDA-approved product labeling for abuse-deterrent opioid formulations5
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
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.
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.
Clinical abuse potential studies
Assess the impact of potentially abuse-deterrent properties in vivo, generally conducted in a drug-experienced, recreational user population.
Determine whether the marketing of a product with abuse-deterrent properties results in meaningful reductions in abuse, misuse, and related adverse clinical outcomes, including addiction, overdose, and death in the post-approval setting.
Additional risks specific to abuse of OxyContin
- OxyContin is for oral use only. Abuse of OxyContin poses a risk of overdose and death. The risk is increased with concurrent use of OxyContin with alcohol and other central nervous system depressants. Taking cut, broken, chewed, crushed, or dissolved OxyContin enhances drug release and increases the risk of overdose and death
- OxyContin contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. OxyContin can be abused and is subject to misuse, addiction, and criminal diversion
References: 1. US Department of Health and Human Services. FDA Supplemental Approval Letter. April 2013. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022272Orig1s014Ltr.pdf. Accessed February 21, 2018. 2. US Food and Drug Administration. Opioid medications—abuse-deterrent opioids. August 21, 2017. https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm. Accessed February 21, 2018. 3. US Food and Drug Administration. Drugs@FDA: FDA approved drug products. NDA 022272. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022272. Accessed February 21, 2018. 4. US Food and Drug Administration. Remarks delivered before FDA's scientific meeting on opioids. July 10, 2017. https://www.fda.gov/NewsEvents/Speeches/ucm566189.htm. Accessed February 21, 2018. 5. US Food and Drug Administration. Abuse-deterrent opioids—evaluation and labeling: guidance for industry. April 2015. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm334743.pdf. Accessed February 21, 2018.