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Journal of Opioid Management

Beatrice Setnik, Kerri A Schoedel, Naama Levy-Cooperman, Megan Shram, Glenn C Pixton, Carl L Roland
With the development of opioid abuse-deterrent formulations (ADFs), there is a need to conduct well-designed human abuse potential studies to evaluate the effectiveness of their deterrent properties. Although these types of studies have been conducted for many years, largely to evaluate inherent abuse potential of a molecule and inform drug scheduling, methodological approaches have varied across studies. The focus of this review is to describe current "best practices" and methodological adaptations required to assess abuse-deterrent opioid formulations for regulatory submissions...
November 2017: Journal of Opioid Management
Klaus Wening, Sebastian Schwier, Hans-J Stahlberg, Eric Galia
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...
November 2017: Journal of Opioid Management
Nikolaj Skak, Torben Elhauge, Jeffrey M Dayno, Karsten Lindhardt
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...
November 2017: Journal of Opioid Management
Beatrice Setnik, Kerri Schoedel, Cindy Bartlett, Chris Dick, Nasrat Hakim, Pierre Geoffroy
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 and drug discrimination qualification test...
November 2017: Journal of Opioid Management
Christopher Altomare, Eric R Kinzler, August R Buchhalter, Edward J Cone, Anthony Costantino
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 been reported on drug abuse websites and forums...
November 2017: Journal of Opioid Management
Theresa A Cassidy, Eileen Thorley, Ryan A Black, Angela DeVeaugh-Geiss, Stephen F Butler, Paul Coplan
OBJECTIVE: To examine abuse prevalence for OxyContin and comparator opioids over a 6-year period prior to and following market entry of reformulated OxyContin and assess consistency in abuse across treatment settings and geographic regions. DESIGN: An observational study examining longitudinal changes using cross-sectional data from treatment centers for substance use disorder. SETTING: A total of 874 facilities in 39 states in the United States within the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO®) surveillance system...
November 2017: Journal of Opioid Management
Lynn R Webster
OBJECTIVE: To provide an overview of available abuse-deterrent opioids (ADOs) and the labeling text that describes abuse-deterrent (AD) properties. DESIGN: A nonsystematic review of ADO literature and regulatory documents guiding their development. OUTCOME MEASURES/RESULTS: A critical assessment and discussion of common routes of opioid abuse, AD methods and properties, US Food and Drug Administration (FDA) study requirements to achieve AD labeling, and brief guide to understanding AD labels...
November 2017: Journal of Opioid Management
J David Haddox
Three concurrent public health problems coexist in the United States: endemic nonmedical use/misuse of opioid analgesics, epidemic overdose fatalities involving opioid analgesics, and endemic chronic pain in adults. These intertwined issues comprise an opioid crisis that has spurred the development of formulations of opioids with abuse-deterrent properties and label claims (OADP). To reduce abuse and misuse of prescription opioids, the federal Food and Drug Administration (FDA) has issued a formal Guidance to drug developers that delineates four categories of testing to generate data sufficient for a description of a product's abuse-deterrent properties, along with associated claims, in its Full Prescribing Information (FPI)...
November 2017: Journal of Opioid Management
Steven D Passik, Howard A Heit, Michael DeGeorge
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 ADFs succeed commercially; but all stakeholders certainly have a responsibility to see that any potential advance, including ADFs, in protecting the public health is fairly and thoroughly evaluated...
November 2017: Journal of Opioid Management
Christopher J Miller, Richard C Dart, Nathaniel P Katz, Lynn R Webster
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)...
November 2017: Journal of Opioid Management
Richard C Dart, Janetta L Iwanicki, Nabarun Dasgupta, Theodore J Cicero, Sidney H Schnoll
OBJECTIVE: We performed a systematic review to answer the question, "Does the introduction of an opioid analgesic with abuse deterrent properties result in reduced overall abuse of the drug in the community?" DESIGN: We included opioid analgesics with abuse deterrent properties (hydrocodone, morphine, oxycodone) with results restricted to the metasearch term "delayed onset," English language, use in humans, and publication years 2009-2016. All articles that contained data evaluating misuse, abuse, overdose, addiction, and death were included...
November 2017: Journal of Opioid Management
Beatrice Setnik
No abstract text is available yet for this article.
November 2017: Journal of Opioid Management
Dan Cohen
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 and modern deterrents, a new and simpler regulatory approval standard for ADF should be adopted by the U.S. Food and Drug Administration. That standard, based on a concept of "Noninterference" increases the potential for a much earlier deployment of ADFs in a broad range of products and allows deterrence to play its most effective role in combatting the national opioid crisis...
November 2017: Journal of Opioid Management
Raeford E Brown
No abstract text is available yet for this article.
November 2017: Journal of Opioid Management
Lynn Webster
No abstract text is available yet for this article.
November 2017: Journal of Opioid Management
Bennet Davis, Kathy Davis, Sandy Bigelow, Patricia Healey
OBJECTIVE: To determine if the use of toothpicks infused with flavoring and flavoring plus the food additive spilanthol (Xerosticks™) improve saliva flow in people with opioid-induced dry mouth. DESIGN: Time series, nonrandomized, double-blind within-subject design. SETTING: Private practice/academic multidisciplinary pain and palliative care clinic. PARTICIPANTS: Ten subjects with opioid-induced dry mouth were recruited, and all finished the study...
September 2017: Journal of Opioid Management
Siddharth Sarkar, Rakesh Lal, Mohit Varshney, Yatan Pal Singh Balhara
BACKGROUND AND AIMS: Tramadol is an opioid agonist which can be potentially used for maintenance treatment of patients with opioid use disorders. This chart review presents the characteristics of individuals with an ICD 10 diagnosis of opioid dependence who were maintained on tramadol for a period of at least 6 months. METHODS: Records of patients seeking treatment for opioid dependence from the outpatient clinic of the National Drug Dependence Treatment Centre, Ghaziabad, India were screened...
September 2017: Journal of Opioid Management
Marc R Larochelle, Noelle M Cocoros, Jennifer Popovic, Elizabeth C Dee, Cynthia Kornegay, Jing Ju, Judith A Racoosin
OBJECTIVE: A risk evaluation and mitigation strategy for extended-release and long-acting (ER/LA) opioid analgesics was approved by the Food and Drug Administration in 2012. Our objective was to assess frequency of opioid tolerance and urine drug testing for individuals initiating ER/LA opioid analgesics. DESIGN: Retrospective cohort study. SETTING: Sentinel, a distributed database with electronic healthcare data on >190 million predominantly commercially insured members...
September 2017: Journal of Opioid Management
Margaret K Pasquale, Richard L Sheer, Jack Mardekian, Elizabeth T Masters, Nick C Patel, Amy R Hurwitch, Jennifer J Weber, Anamaria Jorga, Carl L Roland
OBJECTIVE: To evaluate the impact of a pilot intervention for physicians to support their treatment of patients at risk for opioid abuse. SETTING, DESIGN AND PATIENTS, PARTICIPANTS: Patients at risk for opioid abuse enrolled in Medicare plans were identified from July 1, 2012 to April 30, 2014 (N = 2,391), based on a published predictive model, and linked to 4,353 opioid-prescribing physicians. Patient-physician clusters were randomly assigned to one of four interventions using factorial design...
September 2017: Journal of Opioid Management
Mihran Ara Yenikomshian, Alan G White, Michael E Carson, Louis P Garrison, Gary M Oderda, Joseph E Biskupiak, Patrick R Hlavacek, Carl L Roland
OBJECTIVES: To estimate healthcare resource utilization, associated costs, and number needed to harm (NNH) from a physician's decision to prescribe extended-release (ER) non-abuse-deterrent opioids (non-ADO) as compared to ER ADOs in a chronic pain population. DESIGN: A 12-month probabilistic simulation model was developed to estimate the reduction of misuse and/or abuse from a physician's prescribing decisions for 10,000 patients. Model inputs included probabilities for opioid misuse and/or abuse-related events, opioid discontinuation, and switching from ADO to non-ADO...
September 2017: Journal of Opioid Management
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