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https://www.readbyqxmd.com/read/29750036/oxycodone-hydrochloride-immediate-release-analgesic-for-managing-severe-pain-abuse-deterrent-formulations
#1
EDITORIAL
A H Kibbe, T S Franko, V M Shah
This paper is an expert opinion in response to the development of abuse-deterrent immediate-release tablets containing oxycodone HCl. There is a potential impact, both positive and negative, of this type of dosage form on patients, those suffering from the disease of addiction, health care providers, and the cost of health care.
2018: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/29740351/pain-therapy-guided-by-purpose-and-perspective-in-light-of-the-opioid-epidemic
#2
REVIEW
Amie L Severino, Arash Shadfar, Joshua K Hakimian, Oliver Crane, Ganeev Singh, Keith Heinzerling, Wendy M Walwyn
Prescription opioid misuse is an ongoing and escalating epidemic. Although these pharmacological agents are highly effective analgesics prescribed for different types of pain, opioids also induce euphoria, leading to increasing diversion and misuse. Opioid use and related mortalities have developed in spite of initial claims that OxyContin, one of the first opioids prescribed in the USA, was not addictive in the presence of pain. These claims allayed the fears of clinicians and contributed to an increase in the number of prescriptions, quantity of drugs manufactured, and the unforeseen diversion of these drugs for non-medical uses...
2018: Frontiers in Psychiatry
https://www.readbyqxmd.com/read/29739241/what-s-holding-back-abuse-deterrent-opioid-formulations-considering-12-u-s-stakeholders
#3
Joseph V Pergolizzi, Robert Taylor, Jo Ann LeQuang, Robert B Raffa
There is no greater public health threat at this time in America than the opioid abuse crisis, and a systematic, level-headed, coherent, and unified approach is needed. Among the many things that have been proposed to help reduce opioid abuse is the development of opioid analgesic products in abuse-deterrent formulations (ADFs). This seems to make perfect sense. Areas Covered: In this article, the viewpoints of 12 stakeholders (physicians, pain patients, payers, manufacturers, regulators, law enforcement, hospitals, first responders, elected officials, rehabilitation centers, opioid addicts, and the general public) were considered in terms of how ADF opioids are regarded and might contribute potential impediments to more widespread use...
May 9, 2018: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/29714622/principles-and-methods-of-statistical-assessment-of-abuse-deterrent-opioids
#4
Ling Chen
The FDA Guidance for Industry: Abuse-Deterrent Opioids-Evaluation and Labeling was published in April 2015. Since then questions have been raised regarding how to determine the relative abuse-deterrent (AD) effect of an AD formulation (a test product) compared to an immidiate release (IR) or NonAD extended release (ER) formulation of the same opioid (a positive control) and how to define a responder for responder analysis in clinical abuse potential studies. These questions are reasonable and important for the assessment of AD effect of an AD formulation...
January 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29691801/a-brief-history-of-the-opioid-epidemic-and-strategies-for-pain-medicine
#5
REVIEW
Mark R Jones, Omar Viswanath, Jacquelin Peck, Alan D Kaye, Jatinder S Gill, Thomas T Simopoulos
The opioid epidemic has resulted from myriad causes and will not be solved by any simple solution. Consequent to a staggering increase in opioid-related deaths in the USA, various governmental inputs and stakeholder strategies have been proposed and implemented with varying success. This article summarizes the history of opioid use and explores the causes for the present day epidemic. Recent trends in opioid-related data demonstrate an almost fourfold increase in overdose deaths from 1999 to 2008. Tragically, opioids claimed over 64,000 lives just last year...
April 24, 2018: Pain and Therapy
https://www.readbyqxmd.com/read/29668645/coverage-of-medications-that-treat-opioid-use-disorder-and-opioids-for-pain-management-in-marketplace-plans-2017
#6
Haiden A Huskamp, Lauren E Riedel, Colleen L Barry, Alisa B Busch
BACKGROUND: Efficacious medications to treat opioid use disorders (OUDs) have been slow to diffuse into practice, and insurance coverage limits may be one important barrier. OBJECTIVES: To compare coverage for medications used to treat OUDs and opioids commonly prescribed for pain management in plans offered on the 2017 Health Insurance Marketplace exchanges. RESEARCH DESIGN: We identified a sample of 100 plans offered in urban and in rural counties on the 2017 Marketplaces, weighting by population...
April 17, 2018: Medical Care
https://www.readbyqxmd.com/read/29651781/abuse-deterrent-opioid-formulations-a-key-ingredient-in-the-recipe-to-prevent-opioid-disasters
#7
Aaron J Salwan, Nicholas E Hagemeier, Sam Harirforoosh
The US Food and Drug Administration (FDA) is encouraging the innovation of long-acting opioid formulations that are manipulation-resistant. The purpose of this commentary is to assess the benefits and limitations of abuse-deterrent opioid formulations (ADFs) and discuss their role in mitigating the current opioid epidemic. ADFs have been created with chemical properties that make it difficult for people who non-medically use prescription drugs to crush and dissolve opioid tablets, as well as by combining opioids with antagonists such as naloxone or naltrexone, which are released only when the dosage form has been manipulated or the drug is taken by a non-intended route...
April 12, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29623667/a-review-of-the-opioid-epidemic-what-do-we-do-about-it
#8
REVIEW
Edward A Shipton, Elspeth E Shipton, Ashleigh J Shipton
The opioid epidemic, with its noticeable increase in opioid prescriptions and related misuse, abuse and resultant deaths in the previous 12 years, is a particularly North American phenomenon. Europe, and particularly low- and middle-income countries, appear to be less influenced by this problem. There is undisputable value in using opioids not only in the treatment of acute pain, but in cancer pain as well. However, opioids are progressively being prescribed more and more for chronic non-cancer pain, despite inadequate data on their efficacy...
April 6, 2018: Pain and Therapy
https://www.readbyqxmd.com/read/29619569/america-s-opioid-epidemic-a-comprehensive-review-and-look-into-the-rising-crisis
#9
REVIEW
Peter S Ostling, Kelly S Davidson, Best O Anyama, Erik M Helander, Melville Q Wyche, Alan D Kaye
PURPOSE OF REVIEW: In the USA, there has been a sharp increase in heroin, prescription opiate, and illicitly manufactured fentanyl abuse with overdoses tripling since the 1990s. Several states have been deemed as "high-burden" abuse states where there is a greater proportion of synthetic opiate use. During the same period that prescription limitations were initially implemented throughout the country, the fentanyl epidemic started nationwide. RECENT FINDINGS: In the setting of data demonstrating an almost fourfold increase in overdose deaths from 1999 to 2008, states began restricting access to Food and Drug Agency (FDA) approved opioid medications...
April 4, 2018: Current Pain and Headache Reports
https://www.readbyqxmd.com/read/29608768/a-randomized-double-blind-double-dummy-placebo-controlled-intranasal-human-abuse-potential-study-of-oxycodone-arir-a-novel-immediate-release-abuse-deterrent-formulation
#10
Lynn R Webster, Matthew Iverson, Carmela Pantaleon, Michael D Smith, Eric R Kinzler, Stefan Aigner
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...
March 28, 2018: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/29582347/in-vitro-assessment-of-nasal-insufflation-of-comminuted-drug-products-designed-as-abuse-deterrent-using-the-vertical-diffusion-cell
#11
Heather Boyce, Dan Smith, Steve Byrn, Bhawana Saluja, Wen Qu, Vadim J Gurvich, Stephen W Hoag
In vitro evaluation of abuse deterrent formulations (ADFs) is a challenge since real abuse situations are variable and ADF technology is evolving. Specifically, an assessment of an ADF to deter nasal insufflation would be valuable. In this study, a vertical diffusion cell (VDC) was used to evaluate polyethylene oxide (PEO)-based tablets manipulated by three different forces. The commercially available products Oxycontin®, an ADF, Opana®, and metoprolol tartrate tablet formulations made in our laboratory were studied...
March 26, 2018: AAPS PharmSciTech
https://www.readbyqxmd.com/read/29506559/patient-and-provider-determinants-for-receipt-of-three-dimensions-of-respectful-maternity-care-in-kigoma-region-tanzania-april-july-2016
#12
M M Dynes, E Twentyman, L Kelly, G Maro, A A Msuya, S Dominico, P Chaote, R Rusibamayila, F Serbanescu
BACKGROUND: Lack of respectful maternity care (RMC) is increasingly recognized as a human rights issue and a key deterrent to women seeking facility-based deliveries. Ensuring facility-based RMC is essential for improving maternal and neonatal health, especially in sub-Saharan African countries where mortality and non-skilled delivery care remain high. Few studies have attempted to quantitatively identify patient and delivery factors associated with RMC, and none has modeled the influence of provider characteristics on RMC...
March 5, 2018: Reproductive Health
https://www.readbyqxmd.com/read/29465470/opioid-addiction-diversion-and-abuse-in-chronic-and-cancer-pain
#13
Vijay Kata, Matthew B Novitch, Mark R Jones, Best O Anyama, Erik M Helander, Alan D Kaye
PURPOSE OF REVIEW: The primary cause of overdose death in the United States is related to pharmaceutical opioids. A few particular populations that struggle with adverse outcomes related to opioid abuse are those in palliative care, those with chronic pain, and those receiving pain treatments secondary to cancer or chemotherapy. RECENT FINDINGS: There have been massive efforts to decrease the use of opioid abuse in patient care in a gestalt manner, but palliative care provides unique challenges in applying these reduction tactics used by other specialties...
June 2018: Current Opinion in Supportive and Palliative Care
https://www.readbyqxmd.com/read/29445297/managing-severe-pain-and-abuse-potential-the-potential-impact-of-a-new-abuse-deterrent-formulation-oxycodone-naltrexone-extended-release-product
#14
REVIEW
Joseph V Pergolizzi, Robert Taylor, Jo Ann LeQuang, Robert B Raffa
Proper management of severe pain represents one of the most challenging clinical dilemmas. Two equally important goals must be attained: the humanitarian/medical goal to relieve suffering and the societal/legal goal to not contribute to the drug abuse problem. This is an age-old problem, and the prevailing emphasis placed on one or the other goal has resulted in pendulum swings that have resulted in either undertreatment of pain or the current epidemic of misuse and abuse. In an effort to provide efficacious strong pain relievers (opioids) that are more difficult to abuse by the most dangerous routes of administration, pharmaceutical companies are developing products in which the opioid is manufactured in a formulation that is designed to be tamper resistant...
2018: Journal of Pain Research
https://www.readbyqxmd.com/read/29398162/challenges-involved-in-the-development-and-delivery-of-abuse-deterrent-formulations-of-opioid-analgesics
#15
Joshua P Cohen, Mario Mendoza, Carl Roland
PURPOSE: This commentary examines the development, regulatory, and reimbursement challenges facing abuse-deterrent formulation (ADF) products. METHODS: In January 2017, the Tufts Center for the Study of Drug Development convened a roundtable to explore clinical development, regulatory, and reimbursement challenges with respect to ADFs of opioid analgesics. Roundtable participants, who included a range of pharmaceutical industry and other experts, discussed multiple challenges...
February 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29368961/human-abuse-potential-studies-of-abuse-deterrent-opioids-lessons-from-oral-and-intranasal-studies-with-morphine-abuse-deterrent-extended-release-injection-molded-tablets
#16
Lynn R Webster, Eugene R Viscusi, Colville Brown, Jeffrey M Dayno
BACKGROUND: The development and use of abuse-deterrent (AD) opioids is part of a multifaceted strategy to reduce misuse, abuse, and diversion, while maintaining access for patients with severe pain who may benefit from their analgesic efficacy. Morphine AD, extended-release (ER), injection-molded tablets (morphine-ADER-IMT; ARYMO® ER; Egalet US Inc, Wayne, PA) is approved by the FDA as an AD opioid. As part of the characterization of AD opioids, assessments of their human abuse potential (HAP) are required...
January 25, 2018: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29336948/the-effect-of-a-potentially-tamper-resistant-oxycodone-formulation-on-opioid-use-and-harm-main-findings-of-the-national-opioid-medications-abuse-deterrence-nomad-study
#17
Briony Larance, Timothy Dobbins, Amy Peacock, Robert Ali, Raimondo Bruno, Nicholas Lintzeris, Michael Farrell, Louisa Degenhardt
BACKGROUND: Escalation of pharmaceutical opioid use and harm in North America is well-documented, with similar issues emerging in Australia. One response is the development of tamper-resistant formulations of opioids. A potentially tamper-resistant formulation of controlled-release oxycodone was introduced in Australia in April, 2014, rapidly replacing the non-tamper-resistant formulation. Our study is the most systematic and comprehensive examination of the impact of a new opioid formulation to date, assessing the effect of tamper-resistant formulation of controlled-release oxycodone on population-level opioid use and opioid-related harm (ie, overdose, help-seeking, and treatment-seeking); and opioid use, tampering, and preference for the tamper-resistant formulation of controlled-release oxycodone compared with other drugs or formulations among sentinel populations likely to tamper with pharmaceutical opioids...
February 2018: Lancet Psychiatry
https://www.readbyqxmd.com/read/29325572/modeling-the-relationship-between-women-s-perceptions-and-future-intention-to-use-institutional-maternity-care-in-the-western-highlands-of-guatemala
#18
Emily Peca, John Sandberg
BACKGROUND: Despite global gains, women in hard-to-reach areas are at a relatively higher risk of death and disability related to childbirth. Traditional methods of measuring satisfaction may mask negative experiences (such as disrespect and abuse) that can drive down demand for institutional care. Better measurement of women's perceptions of care quality, especially among marginalized populations with historically low utilization of institutional care, are needed to inform how to improve services and foster greater utilization of (potentially life-saving) clinical care...
January 11, 2018: Reproductive Health
https://www.readbyqxmd.com/read/29304814/service-providers-experiences-of-disrespectful-and-abusive-behavior-towards-women-during-facility-based-childbirth-in-addis-ababa-ethiopia
#19
Anteneh Asefa, Delayehu Bekele, Alison Morgan, Michelle Kermode
BACKGROUND: Disrespect and abuse (D&A) of women during childbirth by the attending staff in health facilities has been widely reported in many countries. Although D&A in labor rooms is recognized as a deterrent to maternal health service utilization, approaches to defining, classifying, and measuring D&A are still at an early stage of development. This study aims to enhance understanding of service providers' experiences of D&A during facility based childbirth in health facilities in Addis Ababa...
January 5, 2018: Reproductive Health
https://www.readbyqxmd.com/read/29228102/benefits-limitations-and-value-of-abuse-deterrent-opioids
#20
Gregory D Curfman, Leo Beletsky, Ameet Sarpatwari
No abstract text is available yet for this article.
January 1, 2018: JAMA Internal Medicine
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