Are physicians fully aware of the potential transgenerational and multigenerational effects of a large opioid misuse in the population?
Authors: Coppola M, Mondola R PMID: 30234919 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - September 22, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Association between the North Carolina Medical Board opioid guideline update and opioid prescriptions in Medicare Part D beneficiaries.
Authors: Gillette C, Bush MA, Rogers KML, Mospan G, Nealy K, DeGeeter M, Robinson AM Abstract OBJECTIVE: To examine if North Carolina (NC) opioid prescribing guidelines were associated with changes in opioid prescribing. METHOD: Retrospective secondary analysis of the Medicare Provider Utilization and Payment Data: Part D Prescriber datasets from 2013 to 2015. PARTICIPANTS: Providers who prescribed at least one opioid from 2013 to 2015 and paid by Medicare Part D. MAIN OUTCOME MEASURE: Per-prescriber Medicare-population adjusted number of analgesic opioid claims and per-prescriber average day supply. Ge...
Source: Journal of Opioid Management - September 22, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Opioid analgesics prescription in people with and without cancer in France.
CONCLUSION: The inconsistency between our findings and existing literature regarding both opioids prescription trends and postdiagnosis pain chronicity in cancer survivors over the medium term suggests possible changes in pain perception and the evolution of cancer pain management strategies. Further research should explore these hypotheses and investigate patient characteristics& effect in cancer pain management. PMID: 30234921 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - September 22, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Impact of rescheduling hydrocodone-combination products in an urban Texas county healthcare system.
CONCLUSION: The scheduling change of HCPs is associated with an immediate decrease in hydrocodone-acetaminophen use at our institution while a simultaneous rise in acetaminophen-codeine products was observed. PMID: 30234922 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - September 22, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Trends in and predictors of hydromorphone administration in US emergency departments (2007-2014).
Authors: Mazer-Amirshahi M, Ladkany D, Mullins PM, Motov S, Perrone J, Nelson LS, Pines JM Abstract OBJECTIVE: To examine recent trends in and predictors of hydromorphone administration in US emergency departments (EDs) compared with other opioids. DESIGN: Retrospective review of data from the National Hospital Ambulatory Medical Care Survey from 2007 to 2014. PARTICIPANTS: All adult ED visits where an opioid analgesic was administered were included. MAIN OUTCOME MEASURES: Trends in and predictors of hydromorphone administration were assessed using survey-weighted logistic regression, comparing hydromor...
Source: Journal of Opioid Management - September 22, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Opioid use: Case-control analyses of worker's compensation data.
Authors: Ott U, Thiese MS, Ronna BB, Hegmann K, Hegmann KT Abstract OBJECTIVES: Working-age adults are disproportionately impacted by opioid misuse. Factors associated with opioid misuse in people with workers compensation (WC) claims are not well studied. WC in some states is a "captured" market making it a more efficient site for researching the opioids epidemic. A pilot study was conducted to identify factors associated with opioid use using a large WC insurer's claims in Utah. METHODS: This was a case-control study using a large WC insurer's database. We conducted secondary data analyses of a de-i...
Source: Journal of Opioid Management - September 22, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

The impact of preinduction fentanyl dosing strategy on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
Authors: Dutta A, Sethi N, Choudhary P, Sood J, Panday BC, Chugh PT Abstract OBJECTIVE: Postoperative nausea and vomiting (PONV) is commonly attributed to opioid analgesics; consequently, perioperative opioid dosage reduction is a common practice. However, inadequate fentanyl analgesia may have adverse implications (sympathetic activation, pain). We conducted this randomized clinical study to analyze whether preinduction fentanyl 3 µg kg-1 administered by different techniques increases incidence of PONV. DESIGN: Randomized-control, prospective, investigator and observer blinded, two-arm, single-center com...
Source: Journal of Opioid Management - September 22, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Provider reasons for discontinuing long-term opioid therapy following aberrant urine drug tests differ based on the type of substance identified.
CONCLUSIONS: High odds of UDT-related discontinuation were found in patients who tested positive for cannabis, alcohol, or illicit substances, relative to nonprescribed prescription medications. PMID: 30234926 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - September 22, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Letter to the Editor: A Case for Opioid Education and Training for Medical Students, Residents, and Allied Health Staff: Response to "Educational Intervention for Physicians to address the risk of Opioid Abuse".
Letter to the Editor: A Case for Opioid Education and Training for Medical Students, Residents, and Allied Health Staff: Response to "Educational Intervention for Physicians to address the risk of Opioid Abuse". J Opioid Manag. 2018 May/Jun;14(3):157 Authors: Bahji A, Camiré D PMID: 30044479 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - July 27, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Associations between pain coping and opioid use: One-month follow-up results of a prospective study in a cohort of traumatic injury patients.
CONCLUSIONS: In the current sample of traumatic injury inpatients, findings indicated that a baseline measure of pain catastrophizing predicts ongoing opioid medication use and dosage at 1-month postdischarge from an inpatient trauma unit. PMID: 30044480 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - July 27, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Daily opioid analgesic use reduces blood insulin levels.
Authors: Mueller C, Chu LF, Lin JC, Ovalle F, Younger JW PMID: 30044481 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - July 27, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Opioid use disorder and homelessness in the Veterans Health Administration: The challenge of multimorbidity.
CONCLUSIONS: OUD is a major risk factor for homelessness. Homeless veterans with OUD have high levels of multimorbidity and greater service use than veterans with either condition alone. Tailored, facilitated access to opioid agonist therapy may improve outcomes for these vulnerable veterans. PMID: 30044482 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - July 27, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

A qualitative study to develop materials educating patients about opioid use before and after total hip or total knee arthroplasty.
CONCLUSIONS: Patients and providers agreed that clearly stated verbal and written messaging is needed beyond what has typically been done regarding opioid expectations. PMID: 30044483 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - July 27, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Communication between nurse care managers and patients who take opioids for chronic pain: Strategies for exploring aberrant behavior.
CONCLUSIONS: These findings provide a potential model for the replication of intensive care management strategies utilizing NCMs in primary care. PMID: 30044484 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - July 27, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Opioid use in the acute setting: A survey of providers at an academic medical center.
CONCLUSION: Most individuals believe opioid analgesics are overused in our specific setting, commonly to satisfy patient requests. In general, providers feel uncomfortable prescribing nonopioid analgesics to patients. PMID: 30044485 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - July 27, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Efficacy and safety of naloxegol for opioid-induced constipation assessed by specific opioid medication, opioid dose, and duration of opioid use.
CONCLUSION: In this post hoc, exploratory analysis, naloxegol 25 mg showed similar efficacy in treating OIC regardless of maintenance opioid type, dose, or duration of opioid use at baseline. PMID: 30044486 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - July 27, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Sourcing of opioid analgesics for nonmedical use: Are veterinarians the latest frontier?
Authors: Russell C, Fischer B, Fidalgo TM PMID: 29733092 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - May 9, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

The parenteral opioid shortage: Causes and solutions.
Authors: Hollingsworth H, Herndon C PMID: 29733093 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - May 9, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Safety profile of intraoperative methadone for analgesia after major spine surgery: An observational study of 1,478 patients.
CONCLUSIONS: Mild-moderate respiratory depression is observed following a one-time dose of intraoperative methadone, and monitoring in an appropriate postoperative setting is recommended. PMID: 29733094 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - May 9, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Assessment of outcomes following high-dose opioid tapering in a Veterans Healthcare System.
Authors: Hundley L, Spradley S, Donelenko S Abstract OBJECTIVE: To assess the impact of tapering of chronic high dose opioid therapy in veterans prompted by the implementation of the Opioid Safety Initiative in 2013. DESIGN: IRB and VA Office of Research and Development-approved retrospective, observational chart review. SETTING: North Florida/South Georgia Veterans Health System Patients: Veterans on high dose opioid therapy (≥300 mg of morphine equivalents per day) for chronic non-cancer pain as of 1/1/2012 with an opioid agreement discontinuation note documented in the medical record were included. Ve...
Source: Journal of Opioid Management - May 9, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Does familiarity with CDC guidelines, continuing education, and provider characteristics influence adherence to chronic pain management practices and opioid prescribing?
Authors: McCalmont JC, Jones KD, Bennett RM, Friend R Abstract OBJECTIVES: (1) To assess providers' experience and knowledge of chronic noncancer pain (CNCP) management. (2) To assess providers' utilization of the Centers for Disease Control and Prevention (CDC) 2016 Guideline for Prescribing Opioids for Chronic Pain. (3) To assess the influence of the 2016 CDC guideline on provider confidence in managing CNCP and adherence to the CDC recommendations. METHODS: A cross-sectional, web-based survey conducted with 417 Oregon prescribing providers, divided into three continuing medical education (CME) groups compose...
Source: Journal of Opioid Management - May 9, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

The effects on patient retention after opioid weaning in an internal medicine residency clinic.
Authors: Opperman CP, Butler MM, Stroud AK, Sun MR Abstract A retrospective, cross-sectional study was completed on 220 patients to determine the effects of implementation of an aggressive policy to curb opioid misuse/abuse in an internal medicine residency clinic. Our findings suggest that the development of a clear and consistent protocol for approaching patients on chronic controlled substances, as well as the initiation of regular didactic sessions addressing chronic pain and pain management, led to a dramatic reduction in the number or opioid prescriptions written by our resident providers without much reducti...
Source: Journal of Opioid Management - May 9, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Oxycodone is safe and effective for general anesthesia.
We examined the use of oxycodone as a single opioid in a well-defined cohort of orthopedic patients undergoing general anesthesia. METHODS: In this retrolective, monocentric investigation, we reviewed data from 83 patients who underwent general anesthesia and received intravenous oxycodone as the sole analgesic (0.075 mg/kg during induction and 0.05 mg/kg during maintenance). The use of oxycodone during general anesthesia and the postoperative pain scores were recorded. Safety was evaluated by the measurement of hemodynamic changes (blood pressure, heart rate), the detection of pathologic changes in the electrocardiogr...
Source: Journal of Opioid Management - May 9, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Long-term opioid users with chronic noncancer pain: Assessment of opioid abuse risk and relationship with healthcare resource use.
Authors: Coutinho AD, Gandhi K, Fuldeore RM, Landsman-Blumberg PB, Gandhi S Abstract OBJECTIVE: Identify opioid abuse risk factors among chronic noncancer pain (CNCP) patients receiving long-term opioid therapy and assess healthcare resource use (HRU) among patients at elevated abuse risk. DESIGN: Data were obtained from an integrated administrative claims database. Classification and Regression Tree (CART) analysis identified risk factors potentially predictive of opioid abuse, which were used to classify the overall population into cohorts defined by levels of abuse risk. Multivariable logistic regression com...
Source: Journal of Opioid Management - May 9, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Does nalbuphine have a niche in managing pain?
Authors: Davis MP, Fernandez C, Regel S, McPherson ML Abstract Nalbuphine has been commercially available for 40 years for the treatment of acute pain; few studies have centered on management of chronic pain. Nalbuphine unique pharmacology is an advantage in pain management. It is µ antagonist, partial κ agonist for G-proteins and beta-arrestin-2. Benefits are related to G-protein interactions resulting in less nausea, pruritus, and respiratory depression than morphine. At low doses, nalbuphine reduces side effects particularly respiratory depression without loss of analgesia when combined with potent o...
Source: Journal of Opioid Management - May 9, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Letter to the Editor: Substance use disorder —Substance-induced disorder clinics for pain-medication addictions and addicted patients' pains: futuristic need for pain physicians sub-specializing in addiction-medicine.
Letter to the Editor: Substance use disorder—Substance-induced disorder clinics for pain-medication addictions and addicted patients' pains: futuristic need for pain physicians sub-specializing in addiction-medicine. J Opioid Manag. 2018 Jan/Feb;14(1):5-7 Authors: Gupta D, Chakrabortty S PMID: 29508890 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - March 8, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

A Rasch analysis of the Current Opioid Misuse Measure for patients with chronic pain.
CONCLUSIONS: The COMM had adequate reliability, measured a distinct construct, and no significant differential item function was found. However, scale use for this sample was questionable, and three items misfit the Rasch model. Replication with a larger sample is needed to ensure the measure's psychometric quality for diagnostic use. PMID: 29508891 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - March 8, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

The role of transdermal compounding in opioid safety.
The objective of this manuscript is to clarify the current state of opioid use and to discuss alternative transdermal analgesic therapies in pain management. Transdermal compounded medications are patient-specific and customizable to include different types of drugs, in various dosage strengths, that are to be delivered simultaneously in one application. Due to the different origins and types of pain, treatments may be most beneficial with multiple classes of drugs with various mechanisms of action. In addition, combination drug therapy may include nontraditional pain management options, and has the ability to maximize the...
Source: Journal of Opioid Management - March 8, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Correlates of opiate misuse based on aberrant urine drug tests for patients on chronic opiate therapy in a safety-net, academic primary care clinic.
CONCLUSIONS: Medication nonadherence and missed appointments for other chronic conditions were significant correlates of opiate misuse. PMID: 29508893 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - March 8, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Discharge prescribing of enteral opioids after initiation as a weaning strategy from continuous opioid infusions in the Intensive Care Unit.
CONCLUSIONS: Utilizing scheduled enteral opioids as a weaning strategy from continuous opioid infusions may place patients at risk of ICU-acquired physical dependence on opioids. PMID: 29508894 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - March 8, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

A snap shot of patients' recall, attitudes, and perceptions of their pain contracts from a family medicine resident outpatient clinic.
CONCLUSIONS: This study highlights limited recall and negative patient attitudes toward the pain contract. Considering the public health concerns with regard to the current opioid epidemic in the United States, additional training of providers, redesign of pain contracts and new models for informing patients about safe chronic pain management may be warranted. PMID: 29508895 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - March 8, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Oxycodone/naloxone in postoperative pain management of surgical patients.
CONCLUSION: Analgesia is crucial to postoperative recovery. Pain control can be achieved a combination of different analgesics, including OXN. This oral analgesic combination can have the potential to minimize side effects, such as opioid-induced constipation and optimize the recovery period. PMID: 29508896 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - March 8, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Hydromorphone use for acute pain: Misconceptions, controversies, and risks.
Authors: Mazer-Amirshahi M, Motov S, Nelson LS Abstract Hydromorphone (HM) is a potent opioid analgesic that is commonly administered in the emergency department (ED) and other acute care settings, such as medical surgical wards. In recent years, there has been a significant increase in the ED administration of HM relative to other opioids. Although HM is an effective analgesic, its use has been commonly implicated in adverse drug events and medication errors. In addition, intravenous HM has potent euphoric effects that may contribute to its abuse liability. There are limited data regarding how acute parenteral adm...
Source: Journal of Opioid Management - March 8, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Treating postoperative pain in the patient who is in recovery or remission from opioid abuse: Focus on Tapentadol.
Authors: Barkin SJ PMID: 29441514 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - February 16, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Can 28-day prescription prevent unintentional medication surplus with 30-day prescription?
Authors: Gupta D, Chakrabortty S PMID: 29441515 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - February 16, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Detection of naltrexone and naltrexol in patients prescribed Embeda ®.
Detection of naltrexone and naltrexol in patients prescribed Embeda®. J Opioid Manag. 2017 May/Jun;13(3):139-140 Authors: West R, Guevara M, Mikel C PMID: 29441516 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - February 16, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

From the Editor: Doctor driven problem or doctor driven solution?
Authors: Webster L PMID: 29308580 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Abuse-deterrent formulations of opioids: Many questions still to answer.
Authors: Brown RE PMID: 29308581 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Abuse-deterrent formulations approval reform: Will clinical correctness or real-world results be used to address the nation's opioid crisis: "Noninterference" as a new approval standard.
Abuse-deterrent formulations approval reform: Will clinical correctness or real-world results be used to address the nation's opioid crisis: "Noninterference" as a new approval standard. J Opioid Manag. 2017 Nov/Dec;13(6):357-362 Authors: Cohen D Abstract To further the public policy objectives of Congress and the country, legislators should now insist that abuse-deterrent formulations (ADFs) be deployed for every C-II opioid and stimulant. The need for these innovative technologies has never been greater. And to most efficiently incentivize innovators to develop and deploy the most effective...
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Letter to the Editor: Opioid Overdose Protection: An Inevitable Need to Address an Alarming Epidemic.
Authors: Setnik B PMID: 29308583 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Do abuse deterrent opioid formulations work?
CONCLUSIONS: Our analysis found that only oxycodone extended release (ER) had information available to evaluate abuse deterrence in the community. In Australia, Canada, and the United States, reformulation of oxycodone ER was followed by marked reduction in measures of abuse. The precise extent of reduced abuse cannot be calculated because of heterogeneous data sets, but the reported reductions ranged from 10 to 90 percent depending on the measure and the duration of follow-up. PMID: 29308584 [PubMed - in process] (Source: Journal of Opioid Management)
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Insights and issues from FDA Advisory Committee meetings on abuse-deterrent opioids.
Authors: Miller CJ, Dart RC, Katz NP, Webster LR Abstract It is the current policy of the US Food and Drug Administration (FDA) to convene expert Advisory Committees to provide input on key regulatory decisions regarding opioid products, including approval and labeling of opioid abuse-deterrent formulations (ADFs). Advisory Committee meetings on ADF opioids consider whether the laboratory and clinical data submitted by the sponsor are sufficient to support marketing approval and labeling of the product with properties expected to deter abuse by specific routes of abuse (ie, oral, intranasal, intravenous). The FDA h...
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Reality and responsibility revisited: Stakeholder accountability in the effort to develop safer opioids.
Authors: Passik SD, Heit HA, DeGeorge M Abstract This supplement is dedicated to an exploration of the science, potential utility, and the current state of abuse-deterrent formulations (ADF) of opioid analgesics. There are many stakeholders in the search for safer pain treatments in general, and safer opioid therapy in particular. Healthcare providers, patients, third-party payors, law enforcement and government regulators, the pharmaceutical industry, and the media all have a stake in seeing pain treated and addiction and overdose avoided. As it applies to ADFs, obviously not everyone has a stake in seeing that AD...
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Opioids with abuse-deterrent properties: A regulatory and technological overview.
This article reviews the epidemiology of the crisis as background for the development of OADP, summarizes the FDA Guidance for Industry regarding abuse-deterrent technologies, and provides an overview of some technologies that are currently employed or are under study for incorporation into OADP. Such technologies include physical and chemical barriers to abuse, combined formulations of opioid agonists and antagonists, inclusion of aversive agents, use of delivery systems that deter abuse, development of new molecular entities and prodrugs, and formulation of products that include some combination of these approaches. Opio...
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Interpreting labels of abuse-deterrent opioid analgesics.
CONCLUSIONS: The FDA has issued guidance as incentive and direction to industry to develop ADOs as one component of a multi-pronged public-health strategy to combat opioid abuse and misuse. The guidance describes separate categories of premarket and postmarket studies and makes recommendations for claims that may be made based on study findings. Ten ADOs have FDA-approved labeling attesting to AD properties. Available formulations that fail to conform to FDA guidance in study and labeling recommendations cannot be considered ADO. Formulations with AD properties are expected to reduce risk compared to the same agents withou...
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Abuse of reformulated OxyContin: Updated findings from a sentinel surveillance sample of individuals assessed for substance use disorder.
CONCLUSION: In the postmarket setting, limitations and methodologic challenges in abuse measurement exist and it is difficult to isolate singular impacts of any one intervention given the complexity of prescription opioid abuse. Expectations for a reasonable threshold of abuse for any one ADF product or ADF opioids as a class are still uncertain and undefined. A significant decline in abuse prevalence of reformulated OxyContin was observed 5 years after its reformulation among this treatment sample of individuals assessed for substance use disorder that was lower historically for the original formulation of this product. ...
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.
Authors: Altomare C, Kinzler ER, Buchhalter AR, Cone EJ, Costantino A Abstract The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have be...
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Intranasal abuse potential of an abuse-deterrent oxycodone formulation compared to oxycodone immediate release and placebo in nondependent, recreational opioid users.
Authors: Setnik B, Schoedel K, Bartlett C, Dick C, Hakim N, Geoffroy P Abstract OBJECTIVE: To assess the intranasal (IN) human abuse potential of ELI-200, a novel immediate-release (IR) oxycodone formulation containing sequestered naltrexone. DESIGN: Randomized, double-blind, double-dummy, active and placebo-controlled, five-way crossover study. Pharmacodynamics, safety, and pharmacokinetics (PKs) were evaluated for up to 36 hours postdose. SETTING: Single site in Canada (INC Research Toronto). PARTICIPANTS: Healthy male and female nondependent recreational opioid users underwent a naloxone challenge an...
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Abuse-deterrent features of an extended-release morphine drug product developed using a novel injection-molding technology for oral drug delivery.
Authors: Skak N, Elhauge T, Dayno JM, Lindhardt K Abstract OBJECTIVE: A novel technology platform (Guardian™ Technology, Egalet Corporation, Wayne, PA) was used to manufacture morphine abuse-deterrent (AD), extended-release (ER), injection-molded tablets (morphine-ADER-IMT; ARYMO® ER [morphine sulfate] ER tablets; Egalet Corporation), a recently approved morphine product with AD labeling. The aim of this article is to highlight how the features of Guardian™ Technology are linked to the ER profile and AD characteristics of morphine-ADER-IMT. RESULTS: The ER profile of morphine-ADER-IMT is attribu...
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research

Application of hot-melt extrusion technology in immediate-release abuse-deterrent formulations.
Authors: Wening K, Schwier S, Stahlberg HJ, Galia E Abstract OBJECTIVE: Hot-melt extrusion (HME) technology has been used for manufacturing extended-release abuse-deterrent formulations (ADFs) of opioid-type analgesics with improved tamper-resistant properties. Our objective was to describe application of this technology to immediate-release (IR) ADFs. DESIGN: For development of a sample IR ADF (hydrocodone 10 mg/acetaminophen 325 mg) based on HME, feasibility studies were performed using different excipients. The formulation selected for further development was evaluated via in vitro test battery. Moreover, in...
Source: Journal of Opioid Management - January 10, 2018 Category: Addiction Tags: J Opioid Manag Source Type: research