Abuse Deterrent Research Articles

What I like – what I don't!

Practical Pre-SchoolVol. 2015, No. 170 Learning Area CoveredWhat I like – what I don't!Brenda WilliamsBrenda WilliamsSearch for more papers by this authorBrenda WilliamsPublished Online:18 Feb 2015https://doi.org/10.12968/prps.2015.170.iAboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article FiguresReferencesRelatedDetailsCited byAversion liquid-filled drug releasing capsule (3D-RECAL): A novel technology for the development of immediate release abuse deterrent formulations using a fused deposition modelling (FDM) 3D printerInternational Journal of Pharmaceutics, Vol. 621 2 March 2015Volume 2015Issue 170ISSN (print): 1366-610XISSN (online): 2052-4587 Metrics History Published online 18 February 2015 Published in print 2 March 2015 Information© MA Education LimitedPDF download

How did you know you got the right pill? Prescription opioid identification and measurement error in the abuse deterrent formulation era

Background Self-report of nonmedical prescription opioid use (NMPU) is a cornerstone of drug abuse surveillance, policymaking, and treatment service planning, but misclassification creates bias and may confuse or undermine NMPU estimates [1]. We detected old OxyContin (OC) abuse reports long after a reformulated version (OP) was released (August 2010). This study explored sources of possible NMPU misclassification and proposed solutions. Materials and methods A mixed-methods approach identified demographic, behavioral, and cognitive factors influencing endorsement of old formulations in: a) multivariable regression analyses of NMPU data from the ASI-MV surveillance program [2] examined predictors of endorsing old (vs. new) formulations during the post-reformulation period (n = 8032); b) prevalence estimates of OC availability from an online recreational drug user forum survey (fall 2013; n = 459); and c) semistructured interviews (n = 29) and cognitive interviews (n = 7) among residential and outpatient substance abuse treatment program clients reporting past 2-year use of OC/OP. A coding guide identified patterns and themes of misidentification in transcribed interviews.

Statistical assessment for abuse deterrent formulation in clinical abuse potential studies

s / Drug and Alcohol Dependence 146 (2015) e202–e284 e245 Patterns of concurrent substance use among prescription stimulant misusers: Results from the national survey on drug use and health Lian-Yu Chen1, R. Crum1,2,3, Christopher N. Kaufmann1, Silvia S. Martins4, Eric C. Strain2, R. Mojtabai1,2 1 Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States 2 Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States 3 Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States 4 Epidemiology, Mailman School of Public Health, New York, NY, United States Aims: To examine patterns of concurrent substance use among adults who used prescription stimulants non-medically. Methods: We used latent class analysis (LCA) to examine patterns of past-year problematic substance (i.e. had any criteria of abuse or dependence) in a sample of 6244 adult participants of NSDUH 2006–2011 who reported past-year non-medical use of prescription stimulants. Multivariate latent regression was used to determine the association of socio-demographics, mental health and deviant behavior characteristics with the latent classes. Results: A four-class model had the best model fit. The largest class was comprised of individuals with low probabilities of any problematic substance use (low substance users, 49.1%); the smallest class was comprised of individuals with high probabilities of problematic use of multiple drugs and alcohol (polysubstance users, 5.3%). A third class was comprised of those who were problematic users of all types of prescription drugs (prescription drug users, 11.8%). A fourth class included participants with high probabilities of problematic alcohol and marijuana use (33.8%). Regression results showed that prescription drug users and polysubstance usersweremore likely to report past-yearmental health problems, deviant behaviors, and mental or substance treatment use, while alcohol/marijuana users reported more deviant behaviors andsubstance treatmentuse, compared to lowsubstanceusers. Conclusions: Nonmedical users of prescription stimulants are a heterogeneous group, with a large subgroup rarely having any substance problems. These sub-groups have distinct patterns of mental health comorbidity, behavior problems and service use, which can offer implications for prevention and treatment of nonmedical stimulant use. Financial support: DA023186. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.132 Statistical assessment for abuse deterrent formulation in clinical abuse potential studies

Anticipated and unanticipated consequences of abuse deterrent formulations of opioid analgesics.

This is an important finding, despitesome flaws in the study, which raises important publichealth concerns. In this context, some history for thosenot well-versed in the current epidemic of prescriptionopioid abuse might be helpful.The abuse problemhas its roots in two major devel-opments in the 1990s. The first was a recommenda-tion from the Joint Commission on Accreditation ofHealthcare Organizations, which emphasized thatpain should be treated as the fifth vital sign, andaccordingly, there should be less trepidation aboutusing potent opioids to relieve pain.

Patterns of concurrent substance use among prescription stimulant misusers: Results from the national survey on drug use and health

s / Drug and Alcohol Dependence 146 (2015) e202–e284 e245 Patterns of concurrent substance use among prescription stimulant misusers: Results from the national survey on drug use and health Lian-Yu Chen1, R. Crum1,2,3, Christopher N. Kaufmann1, Silvia S. Martins4, Eric C. Strain2, R. Mojtabai1,2 1 Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States 2 Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States 3 Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States 4 Epidemiology, Mailman School of Public Health, New York, NY, United States Aims: To examine patterns of concurrent substance use among adults who used prescription stimulants non-medically. Methods: We used latent class analysis (LCA) to examine patterns of past-year problematic substance (i.e. had any criteria of abuse or dependence) in a sample of 6244 adult participants of NSDUH 2006–2011 who reported past-year non-medical use of prescription stimulants. Multivariate latent regression was used to determine the association of socio-demographics, mental health and deviant behavior characteristics with the latent classes. Results: A four-class model had the best model fit. The largest class was comprised of individuals with low probabilities of any problematic substance use (low substance users, 49.1%); the smallest class was comprised of individuals with high probabilities of problematic use of multiple drugs and alcohol (polysubstance users, 5.3%). A third class was comprised of those who were problematic users of all types of prescription drugs (prescription drug users, 11.8%). A fourth class included participants with high probabilities of problematic alcohol and marijuana use (33.8%). Regression results showed that prescription drug users and polysubstance usersweremore likely to report past-yearmental health problems, deviant behaviors, and mental or substance treatment use, while alcohol/marijuana users reported more deviant behaviors andsubstance treatmentuse, compared to lowsubstanceusers. Conclusions: Nonmedical users of prescription stimulants are a heterogeneous group, with a large subgroup rarely having any substance problems. These sub-groups have distinct patterns of mental health comorbidity, behavior problems and service use, which can offer implications for prevention and treatment of nonmedical stimulant use. Financial support: DA023186. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.132 Statistical assessment for abuse deterrent formulation in clinical abuse potential studies

Developing an evidence-based intervention targeting high-risk migrant workers

s / Drug and Alcohol Dependence 146 (2015) e34–e117 e99 miosis was more robust (time-matched or derived parameters; r>0.4). Conclusions: The PK/PD relationship for abuse potential is highly variable and is influenced by numerous factors, including dosage form manipulation and ROA. Effects unrelated to opioid exposure impact a subject’s drug experience. PK alone cannot be used to reliably assess abuse deterrence in HAP studies. Financial support: Supported by Altreos Research Partners, Inc. and Purdue Pharma LP. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.635 Developing an evidence-based intervention targeting high-risk migrant workers Roman Shrestha1, Michael Copenhaver2 1 Department of Community Medicine & Health Care, University of Connecticut, Farmington, CT, United States 2 Department of Allied Health & Sciences, University of Connecticut, Storrs, CT, United States Aims: Nepal has a concentrated HIV epidemic and labor migrants share the highest burden. The epidemic among migrant workers has been associated with risky sexual behaviors, and with alcohol and drug abuse. The very few HIV prevention efforts that have been attempted with this group have been unsuccessful primarily due to stigma, discrimination, and insufficient availability of culturally relevant evidence-based interventions (EBIs). In order to address this issue, we propose formative research designed to promote the development of an intervention to reduce HIV transmission risk among migrant workers in Nepal. Methods: As we will describe in the presentation of our intervention development process, wewill use the ADAPT-ITT approach for intervention adaptation which will involve focus groups with themembers of the target population and treatmentproviders –we will refine and adapt the Holistic Health Recovery Program (HHRP) – an evidence-based HIV risk reduction behavioral intervention–to HHRP-N(epal) for optimal use with the high-risk migrant population in Nepal. Interview items will focus on the HIV risk profile of the target population and ways to optimize the intervention content (i.e., specific content areas of the original evidence-based HHRP modules to include/exclude, emphasize/abbreviate), delivery modality (group vs. individual), and duration (length/timing). In order to develop a culturally sensitive intervention, the program will draw upon Wiley’s framework that includes accommodation, incorporation, and adaptation. Together, all of these data will inform intervention adaptation and subsequent pilot testing of the adapted intervention. Conclusions:Weexpect that the formative process described in this presentation will provide the empirical foundation necessary to strongly inform a subsequent extramurally funded study of an adapted EBI targeting high-risk migrant workers in Nepal. Financial Support: None. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.636 Examining the association between methadone maintenance treatment and body mass index Stacey C. Sigmon1, Jennifer Fenn2 1 Psychiatry, University of Vermont, Burlington, VT, United States 2 Nursing, University of Vermont, Burlington, VT,

Evaluating the potential impact of a reformulated version of oxycodone upon tampering, non-adherence and diversion of opioids: the National Opioid Medications Abuse Deterrence (NOMAD) study protocol.

A new oxycodone formulation (Reformulated OxyContin® was released in Australia, early 2014. It was developed as a tamper-resistant ('abuse-deterrent') formulation of the drug. We summarize methods used in the National Opioid Medication Abuse Deterrence (NOMAD) study, which will examine: (i) whether there is a reduction in extra-medical use (including via tampering) of OxyContin® following the introduction of Reformulated OxyContin®; (ii) potential changes in extra-medical use of non-abuse-deterrent forms of oxycodone, other pharmaceutical opioids and illicit drugs; (iii) whether methods of tampering with Reformulated OxyContin® become widespread over time; (iv) Reformulated OxyContin®'s attractiveness on the illicit market; and (v) sales, prescriptions and harms related to OxyContin® and other drugs. There are three major components. First, analyses of existing routine data sources such as: pharmaceutical sales; prescribing data; data on drug overdose deaths; and survey data on drug use in the general population and among people who inject drugs; secondly, specific data on OxyContin® collected through the Illicit Drug Reporting System; and thirdly, a prospective cohort of n = 606 people who regularly misuse or tamper with pharmaceutical opioids was formed prior to the introduction of Reformulated OxyContin®, followed-up twice post-release to examine potential changes after Reformulated OxyContin®'s introduction. The study's strengths lie in varied data collections; interrupted time-series analysis; and prospective cohort. To our knowledge, this is one of the most comprehensive and transparently conducted studies conducted to date of the potential impact of an opioid medication upon use, tampering and diversion. Results have the potential to inform policymakers, clinicians, consumers and researchers alike.

SY15-1 * USA ISSUES ON PRESCRIPTION OPIOIDS

INTRODUCTION: The availability of prescription opioids increased several fold in many countries in the 1990s, leading to increasing rates of diversion, abuse and death related to these drugs. Increasing mortality has prompted thousands of local, state or federal interventions in the US. One intervention is abuse deterrent formulations of prescription opioids. We report rates of abuse and diversion of prescription opioids in the United States before and after the introduction of abuse deterrent formulations. METHOD: The Researched Abuse, Diversion and Addiction Related Services (RADARS®) System was created to perform up-to-date surveillance from multiple perspectives. We used all RADARS programs to describe trends in prescription opioids. RESULT: The trends of diversion and abuse after introduction of reformulated oxycodone ER and oxymorphone ER showed marked reductions in abuse cases reported to poison centers, diversion cases in law enforcement and abuse in treatment programs. Deaths associated with poisoning cases have also decreased. Furthermore, the street prices of abuse deterrent products are lower than their crushable versions. CONCLUSION: Oxycodone and oxymorphone tablets that are difficult to crush and solubilize offer one method to reduce abuse of these products. The impact of these new products on overall abuse of prescription opioids is unknown. Language: en

Table of Contents

AbstractAntipsychotics found to increase risk of type 2 diabetes in children and adolescentsParents with mood episodes biased in reporting their children's psychopathologyBipolar disorder not necessarily a lifetime chronic condition: Researchers find four subtypesPCP screening and intervention for drugs a failureUnderage drinking combined with drugs associated with more serious health outcomes than drinking aloneRegular marijuana use harmful for teens' brains: APACRAN RFI releasedA warning on the limitations of abuse deterrence

Who Lost Opioids?

Google “opioid abuse deterrence” and you’ll find a lot of hits from lawyers and elected officials. What you won’t find is a lot of expert thinking from the FDA.That needs to change. FDA Commissioner Hamburg’s March 13, 2014 testimony in front of the Senate HELP Committee) hopefully represent a more aggressive stance by the agency. That’s good. But there needs to be more. The FDA must be the leading voice on the issue of abuse deterrence and the safe use of opioids.At present, politicians and pundits (not to mention trial lawyers) own the conversation. They're the ones talking about it. They're the ones the media goes to when they write about it. Have a look at a sampling of the press coverage surrounding Zohydro and see who's quoted and what they're saying. The struggle over control of the opioid abuse deterrence story is, shall say, not going the right way for the FDA.

Acute Pain: Effective Management Requires Comprehensive Assessment

Pain is among the most common reasons that patients seek medical care, and inadequate assessment may result in suboptimal management. Acute pain in response to trauma or surgery can be complex, variable, and dynamic, but its assessment is often simplistic and brief. One-dimensional rating scale measures of pain severity facilitate rapid evaluation and often form the basis of treatment algorithms. However, additional features of pain should inform the selection of a treatment regimen, and can include pain qualities, duration, impact on functional capabilities, and underlying cause. Patient age, sex, psychosocial features, and comorbid conditions are also important features to consider. Use of a multidimensional tool is recommended for assessing many of these features if time permits. Additionally, clinicians often fail to recognize or consider the potentially detrimental long-term effects of acute pain. As the United States continues to experience a prescription drug crisis, a “universal precautions” approach including abuse risk assessment and abuse deterrence strategies should be implemented for patients receiving opioids. Increased efforts and research are necessary to enhance the utility of available acute pain assessment tools. Developing more comprehensive tools for patient assessment is the first step in achieving the ultimate goal of effective acute pain management. The objectives of this review are to summarize issues regarding the complexity of acute pain and to provide suggestions for its evaluation.

ChemInform Abstract: Current Approaches in Tamper‐Resistant and Abuse‐Deterrent Formulations

AbstractReview: 93 refs.

(404) Extraction testing of a novel extended-release, abuse-deterrent formulation of morphine, Morphine ARER, in common household solvents

Abusers of prescription opioids commonly extract the active ingredient from non-abuse deterrent, extended-release formulations to bypass the intended slow release characteristics and increase the opioid’s bioavailability for injection, smoking, or oral administration. Abuse deterrent products are designed to increase the hurdles required to extract the active ingredient with the ultimate goal of decreasing the misuse and abuse of these formulations for all routes of administration dependent on extraction. The FDA’s Draft Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling (January 2013) recommends that laboratory-based in vitro manipulation and extraction studies be performed to evaluate the physical characteristics of a novel product and to guide the downstream pharmacokinetic (PK) and clinical abuse studies. To assess the abuse deterrent properties of an investigational extended-release formulation of morphine, Morphine ARER, in vitro laboratory testing was performed to assess the extractability of morphine. Five intact and five finely crushed tablets were dissolved in 30 mL of household solvents including water, saline solution, vinegar, coke, pH 2, pH 4, pH 6, pH 10, 5% ethanol, 10% ethanol, 20% ethanol, 40% ethanol, and 90oC water. The percent of morphine released was assessed via liquid chromatography. Morphine ARER did not dose dump morphine under any condition or solution. Water was found to be the best solvent for extraction. Interestingly, the amount of morphine released was largely similar between crushed and intact tablets and reduced in increasing concentrations of ethanol. These data clearly indicate that Morphine ARER was highly resistant to extraction and did not result dose dumping either from intact or ground tablets, even at 30 minutes, which is longer than an abuser would be expected to wait. Funding Provided by Inspirion Delivery Technologies LLC.

(256) The impact of an educational group session on opioid treatment agreement violations

Interventions are needed to decrease the growing epidemic of prescription drug abuse. Opioids treatment agreements are often utilized as an abuse deterrent. The purpose of this study is to evaluate if a one hour educational group session for new patients has an impact on violation of opioid treatment agreement violation. Violation of the opioid treatment agreement results in discharge from the pain management clinic. The educational session provided information by a clinical psychologist to new patients about the nature of pain, theories of pain, and traditional and complimentary treatments for pain.

(448) Practitioners knowledge, attitudes, and practices regarding opioid abuse deterrent formulations

Practitioners play an important role in identification and mitigation of prescription-opioid abuse. Inadequate knowledge regarding the topic can lead to under-vigilance (impeding deterrence) or over-vigilance (impeding legitimate pain-relief). Understanding practitioners’ knowledge, attitudes, and practices (KAP) regarding opioids and abuse-deterrent formulations (ADFs) may help identify gaps and guide development of improved multi–disciplinary pain management strategies. We conducted a survey (paper-based or electronic) at a CME pain conference held in Las Vegas (PAINWeek 2013).

Validation of the only commercially available immunoassay for synthetic cathinones in urine: Randox Drugs of Abuse V Biochip Array Technology

Deterrence of synthetic cathinone abuse is hampered by the lack of a high-throughput immunoassay screen. The Randox Drugs of Abuse V (DOA-V) Biochip Array Technology contains two synthetic cathinone antibodies: Bath Salt I (BSI) targets mephedrone/methcathinone and Bath Salt II (BSII) targets 3',4'-methylenedioxypyrovalerone (MDPV)/3',4'-methylenedioxy-α-pyrrolidinobutiophenone (MDPBP). We evaluated DOA-V synthetic cathinones performance and conducted a full validation on the original assay with calibrators reconstituted in water, and the new assay with calibrators prepared in lyophilized urine; both utilized the same antibodies and were run on the fully automated Evidence® Analyzer. We screened 20 017 authentic military urine specimens and confirmed positives by liquid chromatography-tandem mass spectrometry (LC-MS/MS) for 28 synthetic cathinones. Limits of detection (LOD) for the original and new assays were 0.35 and 0.18 (BSI), and 8.5 and 9.2 µg/L (BSII), respectively. Linearity was acceptable (R(2) >0.98); however, a large negative bias was observed with in-house prepared calibrators. Intra-assay imprecision was <20% BSI-II, while inter-assay imprecision was 18-42% BSI and <22% BSII. Precision was acceptable for Randox controls. Cross-reactivities of many additional synthetic cathinones were determined. Authentic drug-free negative urine pH <4 produced false positive results for BSI (6.3 µg/L) and BSII (473 µg/L). Oxidizing agents reduced BSI and increased BSII results. Sensitivity, specificity, and efficiency of 100%, 52.1%, and 53.0% were obtained at manufacturer's proposed cut-offs (BSI 5 µg/L, BSII 30 µg/L). Performance improved if cut-off concentrations increased (BSI 7.5 µg/L, BSII 40 µg/L); however, there were limited confirmed positive specimens. Currently, this is the first and only fully validated immunoassay for preliminary detection of synthetic cathinones in urine. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

Opioid formulations with sequestered naltrexone: a perspective review.

In response to good-intentioned efforts to correct the traditional undertreatment of pain, opioid prescribing experienced a dramatic increase over the past decade. But there is now concern that the pendulum has swung too far in the opposite direction, with a rise in morbidity and mortality associated with prescription opioid misuse and abuse. Yet despite potential problems, opioids are a mainstay for the treatment of pain and are an important component of a comprehensive pain management strategy. Therefore, the overall goal of pain management is to decrease pain and to improve patient functioning and quality of life, while monitoring for adverse effects or aberrant behaviors. That is, to balance effective chronic pain management with appropriate use of opioids. Toward this end, several abuse deterrent strategies (formulations) have been, and continue to be, developed. Several major ones are reviewed here. These products should be a first step in trying to address diversion and abuse in a manner that does not discriminate against any particular patient and aligns with universal prescribing precautions. They should also comprise only one aspect of an overall opioid risk management plan.

The impact of a reformulation of extended-release oxycodone designed to deter abuse in a sample of prescription opioid abusers

BackgroundPrescription opioid abuse is a significant public health concern that requires strategies to reduce its impact, including development of abuse deterrent formulations. OxyContin®, an extended-release oxycodone (ERO) formulation, has been widely abused. This study assessed the effects of reformulated ERO, designed to be more difficult to manipulate for purposes of intranasal and intravenous abuse, on patterns of opioid abuse among a sample of individuals from rural Appalachia with a history of ERO abuse. MethodsStructured interviews assessing opioid abuse (past 30-day abuse and retrospectively reported abuse prior to the reformulation in August 2010) were completed by 189 individuals between December 2010 and September 2011. ResultsThe past 30-day prevalence and frequency of reformulated ERO abuse through any route (33%, 1.9 days/month), snorting (5%, 0.2 days/month), and injecting (0.5%, <0.1 days/month) were low and infrequent compared to that of IR oxycodone (any route: 96%, 19.5 days/month; snorting: 70%, 10.3 days/month; injecting: 51%, 10.5 days/month) and retrospectively reported abuse of original ERO in August 2010 (any route: 74%, 13.4 days/month; snorting: 39%, 6.0 days/month; injecting: 41%, 8.6 days/month). After the reformulation, the prevalence of original ERO abuse significantly declined while abuse of reformulated ERO remained steadily low. Heroin abuse was rare in this sample. ConclusionsIn this sample, abuse of reformulated ERO was low, and lower than abuse of original ERO retrospectively and IR oxycodone concurrently, particularly through injecting and snorting routes of administration. There was no evidence to suggest that reformulated ERO became a substitute for original ERO.

Tamper-Resistant Opioid Formulations in the Treatment of Acute Pain

Pain-including acute or persistent acute pain-is a common condition that is increasingly being treated with opioids in the United States. The acute pain treatment setting may represent a key target for addressing the growing epidemic of prescription drug abuse occurring hand in hand with the rise in opioid prescribing. Balancing the needs of pain treatment with abuse prevention can be challenging for clinicians. This article identified efforts to balance opioid abuse risks with opioid availability through the extensive experience of the author in this field. In addition, PubMed literature searches using terms such as "prescription opioid abuse", "abuse-deterrent opioids", and "tamper-resistant opioids"; and inspection of the bibliographies of relevant articles were used to identify relevant sources. These multifaceted efforts have included: improving assessment of patient risk for drug misuse, abuse, or diversion; funding of and encouraging referral to addiction treatment programs; access to and widespread use of prescription monitoring programs (PMPs); public knowledge of prescription opioid abuse; proper storage of opioid medications; and development of new formulations designed to resist tampering and deter abuse. This review discusses the problem of prescription opioid abuse and strategies to minimize risk within the context of acute pain treatment, and explores the potential role of tamper-resistant opioid formulations and other abuse deterrence strategies in the area of acute or persistent acute pain management. In order to stem the tide of prescription opioid abuse and preserve the availability of opioids as a much needed analgesic option, a multifaceted approach that includes tamper-resistant opioid formulations-for chronic or acute pain-along with strategies such as improved patient risk assessment, funding for and referral to addiction treatment programs, greater use of PMPs, and raised awareness of prescription opioid abuse is needed.

A practical and ethical solution to the opioid scheduling conundrum

A practical and ethical solution to the opioid scheduling conundrum Michael E Schatman,1 Beth D Darnall21Foundation for Ethics in Pain Care, Bellevue, WA, USA; 2Stanford University School of Medicine, Division of Pain Medicine, Palo Alto, CA, USA Abuse-deterrent formulations (ADFs) of opioids have been in existence since the 1970s,1 with abuse-deterrent mechanisms including physical barriers (eg, barriers to crushing), chemical additives such as opioid antagonists or irritants, and prodrugs that require conversion of the medication into their active forms in the gastrointestinal tract.2 A recent systematic review and meta-analysis3 found no difference between ADFs and non-ADFs in terms of efficacy or adverse events including nausea, vomiting, dizziness, headache, somnolence, constipation, and pruritus. Notably, the efficacy of ADFs in preventing abuse is not yet established, and therefore the authors could only comment on their "potential … to deter or resist some of the common forms of tampering associated with opioid misuse and abuse". While Turk et al2 have elucidated the complexity of producing high-quality research on the efficacy of ADFs to reduce opioid abuse, recent data are encouraging. For example, since Purdue Pharma’s (Stamford, CT, USA) voluntary reformulation of OxyContin® to an ADF in 2010, abuse of the medication has decreased significantly.4–6 As a specific example, National Poison Data System statistics indicated a 36% reduction in abuse exposure for OxyContin following ADF reformulation. Meanwhile, researchers for Purdue Pharma found an increase in abuse exposure for other single-entity oxycodone products and a 42% increase in abuse exposure for heroin during the same time frame.7 Although OxyContin has been the most investigated abuse deterrent formulation, ADFs of other opioids have demonstrated promise in preliminary investigations.8,9