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

Butler, Stephen F.; Cassidy, Theresa A.; Chilcoat, Howard D.; Black, Ryan A.; Landau, Craig; Budman, Simon H.; Coplan, Paul

doi:10.1016/j.jpain.2012.08.008

Cited by 170 publications

(150 citation statements)

References 24 publications

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“…In a larger sample of 140,496 individuals assessed for substance-abuse treatment at 357 centers in the USA between June 2009 and March 2012, the overall rate of abuse of the abuse-deterrent reformulation of oxycodone decreased by 41% for any route and by 66% for non-oral routes compared with historical rates for the original extended-release formulation; oral abuse decreased by 17%. [111] Abuse patterns of extended-release oxymorphone and extended-release morphine were not found to change over the same period ( Figure 5). …”

Section: Differences In Routes Of Abuse Between Populationsmentioning

confidence: 94%

“…[94][95][96][97][98][99] A growing body of evidence suggests that introduction of the abuse-deterrent formulation of oxycodone has been associated with decreased rates of abuse and diversion of this opioid analgesic in the USA. [101,[110][111][112][113][114][115][116][117][118][119]. Cost savings have also been reported to be associated with reductions in abuse following the introduction of the abuse-deterrent reformulation of oxycodone in the USA.…”

Section: Differences In Routes Of Abuse Between Populationsmentioning

confidence: 99%

“…Because analysis is limited to those reporting abuse of oxycodone, a reduction in the percentage of patients reporting abuse through non-oral routes was accompanied by a corresponding increased percentage reporting abuse through oral routes. Reprinted from Butler et al [111], Copyright (2015), with permission from Elsevier. ER: extended-release.…”

Section: Er Morphinementioning

confidence: 99%

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Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Gąsior

Bond

Malamut

2015

Postgraduate Medicine

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Prescription opioid analgesics are an important treatment option for patients with chronic pain; however, misuse, abuse and diversion of these medications are a major global public health concern. Prescription opioid analgesics can be abused via intended and non-intended routes of administration, both intact or after manipulation of the original formulation to alter the drug-delivery characteristics. Available data indicate that ingestion (with or without manipulation of the prescribed formulation) is the most prevalent route of abuse, followed by inhalation (snorting, smoking and vaping) and injection. However, reported routes of abuse vary considerably between different formulations. A number of factors have been identified that appear to be associated with non-oral routes of abuse, including a longer duration of abuse, younger age, male sex and a rural or socially deprived location. The development of abuse-deterrent formulations of prescription opioid analgesics is an important step toward reducing abuse of these medications. Available abuse-deterrent formulations aim to hinder extraction of the active ingredient, prevent administration through alternative routes and/or make abuse of the manipulated product less attractive, less rewarding or even aversive. There are currently five opioid analgesics with a Food and Drug Administration abuse-deterrent label, and a number of other products are under review. A growing body of evidence suggests that introduction of abuse-deterrent opioid analgesics in the USA has been associated with decreased rates of abuse of these formulations. The availability of abuse-deterrent formulations therefore appears to represent an important step toward curbing the epidemic of abuse of prescription opioid analgesics, while ensuring the availability of effective pain medications for patients with legitimate medical need.

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Section: Differences In Routes Of Abuse Between Populationsmentioning

confidence: 94%

Section: Differences In Routes Of Abuse Between Populationsmentioning

confidence: 99%

Section: Er Morphinementioning

confidence: 99%

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Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Gąsior

Bond

Malamut

2015

Postgraduate Medicine

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“…Some formulations of immediate-release (IR) and extended-release (ER) opioids can be manipulated to achieve more rapid drug release and to facilitate alternate routes of administration (i.e., injecting, snorting, and smoking) (6,7). Abuse-deterrent (AD) formulations have been developed to substantially reduce misuse and abuse of opioids by making manipulation more difficult or rendering the manipulated product less attractive and less amenable to alternate routes of administration (8).…”

Section: Introductionmentioning

confidence: 99%

The ALERRT^® instrument: a quantitative measure of the effort required to compromise prescription opioid abuse-deterrent tablets

Cone¹,

Buchhalter²,

Lindhardt³

et al. 2017

The American Journal of Drug and Alcohol Abuse

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Background: US FDA guidance recommends measuring the degree of effort needed to manipulate abuse-deterrent (AD) opioids. The ALERRT ® instrument (PinneyAssociates; Bethesda, MD) uses visual analog scales to assess the labor, effort, and resources necessary to physically compromise AD product candidates in standardized settings. Objective: Use the ALERRT ® instrument for testing morphine abuse-deterrent, extended-release, injection-molded tablets (ADER-IMT) 60 and 100 mg and the comparators immediate-release (IR) morphine sulfate 30 mg and extended-release (ER) morphine sulfate 60 mg. Methods: Four technicians tested the products using 10 household tools. The ALERRT instrument quantified effort (all tools) and time (3 preselected tools) required for manipulation. Results: Morphine-ADER-IMT 60 and 100 mg were difficult to manipulate, as demonstrated by high scores (mean range, 71.0−99.0 and 77.0−99.5, respectively). IR and ER morphine sulfate were easy to manipulate (low scores; mean range, 2.0−14.8 and 2.3−17.5, respectively). Statistically significant mean differences between morphine-ADER-IMT and comparators' ALERRT scores were observed. Manipulations of morphine-ADER-IMT 60 and 100 mg for 300 seconds failed to produce substantial powdering. Manipulations of IR morphine sulfate (mean range, 65.5−175.8 seconds) and ER morphine sulfate (49.3−163.0 seconds) produced substantial to complete powdering in 92% of tablets. Conclusions: Morphine-ADER-IMT was extremely difficult to manipulate versus non-AD formulations of morphine. The ALERRT system differentiated the degree of effort for manipulation of morphine-ADER-IMT and non-AD morphine formulations, indicating sensitivity of this instrument as part of Category 1 testing. By measuring the degree of effort required for manipulation, the ALERRT instrument provides an empirical assessment into the relative difficulty of manipulating opioid analgesics for abuse.

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“…It has been shown that 'crush-resistant' tablets, the most notable of which is OxyContin R (oxycodone ER, Purdue Pharma L.P., CT, USA), are capable of reducing abuse by nonoral routes (i.e., nasal, injection); however, abuse of these products by the oral route is still reported [3,7]. Similarly, manipulation of tablets before oral administration, by methods such as chewing or dissolving in the mouth, is still reported for crush-resistant tablets, such as for reformulated OxyContin [3,7]. Xtampza R ER (Oxycodone DETERx R , Collegium Pharmaceutical, Inc., MA, USA) is an ER, microspherein-capsule, abuse-deterrent formulation of oxycodone.…”

mentioning

confidence: 99%

The Comparative Pharmacokinetics of Physical Manipulation by Crushing of Xtampza ^® ER Compared with OxyContin ^®

Brennan¹,

Kopecky

Marseilles

et al. 2017

Pain Manag.

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Aim:To further characterize the pharmacokinetics of Xtampza R ER. Subjects & methods:This was an openlabel, randomized, active-controlled, five-treatment, five-period, naltrexone-blocked, cross-over study. Healthy subjects received five equivalent oxycodone doses: Xtampza ER (intact or crushed), OxyContin R (intact or crushed) or immediate-release (IR) oxycodone (crushed). Blood samples were collected to assess oxycodone concentrations. Results: Crushed and intact Xtampza ER resulted in lower peak plasma concentrations compared with crushed oxycodone IR; crushed and intact Xtampza ER were bioequivalent. Crushed OxyContin exhibited a rapid increase in plasma oxycodone and was bioequivalent to crushed oxycodone IR. Conclusion: This second pharmacokinetic study demonstrated that Xtampza ER maintains its ER properties after crushing, unlike OxyContin, which failed to retain its ER properties after crushing.

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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

Cited by 170 publications

References 24 publications

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

The ALERRT^® instrument: a quantitative measure of the effort required to compromise prescription opioid abuse-deterrent tablets

The Comparative Pharmacokinetics of Physical Manipulation by Crushing of Xtampza ^® ER Compared with OxyContin ^®

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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

Cited by 170 publications

References 24 publications

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

Routes of abuse of prescription opioid analgesics: a review and assessment of the potential impact of abuse-deterrent formulations

The ALERRT® instrument: a quantitative measure of the effort required to compromise prescription opioid abuse-deterrent tablets

The Comparative Pharmacokinetics of Physical Manipulation by Crushing of Xtampza ® ER Compared with OxyContin ®

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The ALERRT^® instrument: a quantitative measure of the effort required to compromise prescription opioid abuse-deterrent tablets

The Comparative Pharmacokinetics of Physical Manipulation by Crushing of Xtampza ^® ER Compared with OxyContin ^®