Intranasal abuse potential study
- A randomized, double-blind, placebo-controlled, 5-period crossover pharmacodynamic study
- The 5 treatment arms used intranasally administered finely crushed OxyContin 30 mg tablets, coarsely crushed OxyContin 30 mg tablets, finely crushed original OxyContin 30 mg tablets, powdered oxycodone HCI 30 mg, and placebo (data for 3 treatment arms shown)
- 30 subjects dosed, 27 subjects completed the study
- Subjects were recreational opioid users with a history of intranasal drug abuse
- Incomplete dosing due to granules falling from the subjects' nostrils occurred in 34% (n=10) of subjects with finely crushed OxyContin, compared with 7% (n=2) of subjects with finely crushed original OxyContin and no subjects with powdered oxycodone HCl, which may have impacted the results
Recreational opioid users reported less Drug Liking with finely crushed OxyContin
Drug Liking was measured on a bipolar VAS scale of 0 to 100: 0=negative response/maximum disliking; 50=neutral response of neither liking nor disliking; and 100=positive response/maximum liking.
- Abuse-deterrent properties do not prevent or reduce the risk of addiction1
- 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
Recreational opioid users reported less desire to Take Drug Again with finely crushed OxyContin
Desire to Take Drug Again was measured on a bipolar VAS scale of 0 to 100: 0=maximum negative response "definitely would not take drug again"; 50=neutral response; and 100=maximum positive response "definitely would take drug again".
In an analysis with...
Finely crushed OxyContin vs oxycodone HCI powder
- ~56% (n=15) reported some reduction in Drug Liking
- ~44% (n=12) had no reduction in Drug Liking
- 33% (n=9) reported reductions of at least 30% in Drug Liking
- ~22% (n=6) reported reductions of at least 50% in Drug Liking
Finely crushed OxyContin vs finely crushed original OxyContin
- ~57% (n=16) reported some reduction in Drug Liking
- ~43% (n=12) had no reduction in Drug Liking
- 36% (n=10) reported reductions of at least 30% in Drug Liking
- ~29% (n=8) reported reductions of at least 50% in Drug Liking
Additional Important Safety Information
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. All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
Reference: 1. 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.