ISSUE 1522
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Development of abuse-deterrent opioid products, including reformulation of existing products, has become a priority for drug manufacturers and public health advocates. Since our last article on this subject,1 several new abuse-deterrent opioid formulations have been approved by the FDA,2,3 including an oxycodone tablet formulation (Roxybond – Inspirion) that is the first immediate-release opioid product FDA-approved to include claims of abuse deterrence in its labeling.4 No opioid formulation prevents consumption of a large number of intact dosage units, the most common method of abuse. Abuse-deterrent formulations have one or more properties that make their intentional nontherapeutic use more difficult, less attractive, or less rewarding.5
LABELING
... more- Abuse-deterrent opioid formulations. Med Lett Drugs Ther 2015; 57:119.
- A new abuse-deterrent opioid – Xtampza ER. Med Lett Drugs Ther 2016; 58:77.
- Arymo ER – a new abuse-deterrent morphine formulation. Med Lett Drugs Ther 2017; 59:68.
- An abuse-deterrent IR oxycodone formulation (Roxybond). Med Lett Drugs Ther 2017; 59 (in press).
- FDA. Abuse-deterrent opioids – evaluation and labeling: guidance for industry. April 2015. Available at: www.fda.gov. Accessed May 25, 2017.
- L Degenhardt et al. The introduction of a potentially abuse deterrent oxycodone formulation: early findings from the Australian National Opioid Medications Abuse Deterrence (NOMAD) study. Drug Alcohol Depend 2015; 151:56.
- PM Coplan et al. Changes in oxycodone and heroin exposures in the National Poison Data System after introduction of extended-release oxycodone with abuse-deterrent characteristics. Pharmacoepidemiol Drug Saf 2013; 22:1274.
- TJ Cicero et al. Effect of abuse-deterrent formulation of OxyContin. N Engl J Med 2012; 367:187.
- TA Cassidy et al. Changes in prevalence of prescription opioid abuse after introduction of an abuse-deterrent opioid formulation. Pain Med 2014; 15:440.
- MR Larochelle et al. Rates of opioid dispensing and overdose after introduction of abuse-deterrent extended-release oxycodone and withdrawal of propoxyphene. JAMA Intern Med 2015; 175:978.
- CS Hwang et al. Impact of abuse-deterrent OxyContin on prescription opioid utilization. Pharmacoepidemiol Drug Saf 2015; 24:197.
- PM Coplan et al. The effect of an abuse-deterrent opioid formulation (OxyContin) on opioid abuse-related outcomes in the postmarketing setting. Clin Pharmacol Ther 2016; 100:275.
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Article code: 1522b
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