Positive subjective measures in abuse liability studies and real-world nonmedical use: Potential impact of abuse-deterrent opioids on rates of nonmedical use and associated healthcare costs

White, Alan G.; LeCates, Joseph; Birnbaum, Howard G.; Cheng, Mph Wendy; Roland, PharmD Carl L.; Mardekian, Jack

doi:10.5055/jom.2015.0269

Cited by 17 publications

(3 citation statements)

References 11 publications

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“…Conclusively translating these data to a real-world population is also difficult. However, a meta-analysis reported that a 5-mm reduction in overall drug-liking E max for an abuse-deterrent formulation of ER oxycodone would be expected to produce a 10.1% reduction in the nonmedical use rate [18]. Here we report that crushed intranasal oxycodone ARIR led to a 16-mm reduction in overall drug liking E max compared with crushed intranasal IR oxycodone.…”

Section: Discussionmentioning

confidence: 52%

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Intranasal Human Abuse Potential Study of Oxycodone ARIR, a Novel, Immediate-Release, Abuse-Deterrent Formulation

Webster

Iverson²,

Pantaleon³

et al. 2018

Pain Medicine

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Objective Prescription opioid abuse continues to be a public health concern. Oxycodone ARIR is an immediate-release (IR) oxycodone tablet composed of multiple overlapping barriers that deter manipulation of the tablet for non-oral abuse. Design This randomized, double-blind, double-dummy, active- and placebo-controlled, four-way crossover, intranasal human abuse potential study assessed the pharmacodynamics and pharmacokinetics of crushed intranasal oxycodone ARIR compared with crushed intranasal IR oxycodone and intact oral oxycodone ARIR. Outcome Measures Pharmacodynamic end points included mean maximum drug liking (Emax), as measured by subjects on a bipolar 100-mm visual analog scale (primary), and desire to take the drug again, overall drug liking, drug high, and good effects (secondary). Pharmacokinetic assessments included peak concentration and time to peak concentration. Results Twenty-nine subjects completed the treatment phase. Crushed intranasal oxycodone ARIR demonstrated a significant reduction of 46.9% and 23.4% in drug liking Emax compared with crushed intranasal IR oxycodone and intact oral oxycodone ARIR, respectively (P < 0.0001 for both). Significant reductions also were observed in desire to take the drug again, drug high, overall drug liking, and good effects when comparing crushed intranasal oxycodone ARIR with crushed intranasal IR oxycodone and intact oral oxycodone ARIR (P < 0.001 for all). Crushed intranasal oxycodone ARIR exhibited lower peak oxycodone plasma concentrations and slower time to peak concentration compared with crushed intranasal IR oxycodone and intact oral oxycodone ARIR. All treatments were well tolerated; adverse effects were typical of opioids or intranasal administration. Conclusions These data indicate that oxycodone ARIR has the potential to reduce abuse via the intranasal route.

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Section: Discussionmentioning

confidence: 52%

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Intranasal Human Abuse Potential Study of Oxycodone ARIR, a Novel, Immediate-Release, Abuse-Deterrent Formulation

Webster

Iverson²,

Pantaleon³

et al. 2018

Pain Medicine

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“…These methods are gold standards in drug approval processes (Carter et al, 2009; Carter & Griffiths, 2009; Henningfield & Keenan, 1993). Comparative abuse liability assessment methodology can accommodate multiple compounds and formulation types (e.g., Vansickel, Weaver, & Eissenberg, 2012; Walsh, Nuzzo, Lofwall, & Holtman, 2008), and results from studies on opioids have demonstrated predictive validity with regard to community rates of non-medical use, and associated health care costs (White et al, 2015). The hallmark of these methods involves double-blind, placebo-controlled comparisons of several related compounds, multiple doses, or formulations, including a well-studied variant as a reference compound.…”

Section: Opportunities To Leverage Methodological Advances From Opioimentioning

confidence: 99%

Sweet flowers are slow, and weeds make haste: leveraging methodology from research on tobacco, alcohol, and opioid analgesics to make rapid and policy-relevant advances in cannabis science

Herrmann

Jarvis

Sparks

et al. 2018

International Review of Psychiatry

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The legalization of medical and recreational cannabis use has occurred ahead of science. The current evidence base has poor utility for determining if cannabis products can meet the standards of safety, efficacy, and quality intrinsic to modern medicine, and for informing regulation of cannabis as a legal intoxicant. Individual jurisdictions that pass cannabis reforms may not have adequate resources to support the level of new scientific research needed to inform regulatory actions; this could make it difficult to keep a rapidly growing multi-billion-dollar cannabis industry in check. Further, the present lack of evidence-based regulatory oversight for cannabis parallels the climates that gave rise to the tobacco and prescription opioid epidemics, suggesting that continued omission may result in negative public health consequences. However, translating a methodological framework developed through research on these compounds may promote rapid advances in cannabis science germane to regulatory knowledge gaps. The present review highlights specific advancements in these areas, as well as in alcohol regulation, that are prime for informing policy-relevant cannabis science, and also offers some recommendations for evidence-based regulatory policy. Resulting progress may directly inform both regulation of cannabis in both medical and licit recreational drug frameworks, and new cannabis-related public health initiatives.

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“…Using this algorithm, we estimated that an additional 19.43 percent reduction in misuse/abuse rate via IN route of administration for morphine-ARER relative to non-ADF ER morphine can be expected based on the observed difference in drug liking scores ( Figure 2). 14…”

Section: Estimating Potential Benefits Of Abuse-deterrent Propertiesmentioning

confidence: 99%

<p>Healthcare Resource Use and Cost: The Impact of Adopting an Abuse-Deterrent Formulation of Extended Release Morphine</p>

Rossiter¹,

Kwong²,

Marrett³

2020

CEOR

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Background: Development of abuse-deterrent formulations (ADFs) of prescription opioids (RxO) is an important step toward reducing misuse and abuse. Morphine-ARER (MorphaBond™ ER) is an extended-release (ER) morphine sulfate tablet formulated to deter misuse/abuse via intravenous (IV) and intranasal (IN) routes of administration. Objective: A model was developed to estimate the budget impact to a hypothetical commercial health plan of 10 million members 2 years after adding morphine-ARER to drug formulary. Methods: We analyzed incremental health care resource use (HCRU) associated with RxO misuse/abuse based on a health plan's RxO formulary coverage and patterns of misuse/abuse. Misuse/abuse rates, incremental HCRU and associated costs were based on the 2015 National Survey on Drug Use and Health, an analysis of claims from OptumHealth Care Solutions, Inc. (2013-2015) and published literature. RxO formulary shares were based on 2016-2017 Symphony Retail Prescription data. Morphine-ARER was assumed to capture 20 and 30 percent from branded and 0.3 and 0.6 percent from generic non-ADF ER morphine, in the first and second years, respectively. Proportions of misuse/abuse deterred by physical/ chemical properties of morphine-ARER were assumed to be 90 percent via IV and 60 percent via IN administration, with further IN deterrence based on results from morphine-ARER's human abuse liability study.

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Positive subjective measures in abuse liability studies and real-world nonmedical use: Potential impact of abuse-deterrent opioids on rates of nonmedical use and associated healthcare costs

Cited by 17 publications

References 11 publications

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Intranasal Human Abuse Potential Study of Oxycodone ARIR, a Novel, Immediate-Release, Abuse-Deterrent Formulation

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Intranasal Human Abuse Potential Study of Oxycodone ARIR, a Novel, Immediate-Release, Abuse-Deterrent Formulation

Sweet flowers are slow, and weeds make haste: leveraging methodology from research on tobacco, alcohol, and opioid analgesics to make rapid and policy-relevant advances in cannabis science

<p>Healthcare Resource Use and Cost: The Impact of Adopting an Abuse-Deterrent Formulation of Extended Release Morphine</p>

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