Abuse-Deterrent Opioid Formulations
August 31, 2015 (Issue: 1476)
Development of abuse-deterrent opioid products,
including reformulation of existing products, has
become a priority for drug manufacturers and public
health advocates. Three available opioid formulations,
OxyContin (Purdue), Embeda (Pfizer), and...more
- FDA. Abuse-deterrent opioids – evaluation and labeling: guidance for industry. April 2015. Available at: www.fda.gov. Accessed August 20, 2015.
- SC Harris et al. Abuse potential, pharmacokinetics, pharmacodynamics, and safety of intranasally administered crushed oxycodone HCl abuse-deterrent controlled-release tablets in recreational opioid users. J Clin Pharmacol 2014; 54:468.
- A morphine/naltrexone combination (Embeda) for pain. Med Lett Drugs Ther 2010; 52:22.
- J Stauffer et al. Subjective effects and safety of whole and tampered morphine sulfate and naltrexone hydrochloride (ALO-01) extended-release capsules versus morphine solution and placebo in experienced non-dependent opioid users: a randomized, double-blind, placebo-controlled, crossover study. Clin Drug Investig 2009; 29:777.
- Extended-release hydrocodone (Hysingla ER) for pain. Med Lett Drugs Ther 2015; 57:71.
- Extended-release hydrocodone (Zohydro ER) for pain. Med Lett Drugs Ther 2014; 56:45.
- Press release. Zogenix receives FDA approval of new formulation of Zohydro® ER. January 30, 2015. Available at: www.zogenix. com. Accessed August 20, 2015.
- SG Severtson et al. Reduced abuse, therapeutic errors, and diversion following reformulation of extended-release oxycodone in 2010. J Pain 2013; 14:1122.
- SF Butler et al. Abuse rates and routes of administration of reformulated extended-release oxycodone: initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment. J Pain 2013; 14:351.
- NE Sessler et al. Reductions in reported deaths following the introduction of extended-release oxycodone (OxyContin) with an abuse-deterrent formulation. Pharmacoepidemiol Drug Saf 2014; 23:1238.
- JR Havens et al. The impact of a reformulation of extended-release oxycodone designed to deter abuse in a sample of prescription opioid abusers. Drug Alcohol Depend 2014; 139:9.
- 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.
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