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https://www.readbyqxmd.com/read/29041942/patient-reported-health-related-quality-of-life-work-productivity-and-activity-impairment-during-treatment-with-alo-02-extended-release-oxycodone-and-sequestered-naltrexone-for-moderate-to-severe-chronic-low-back-pain
#1
Arnold J Weil, Elizabeth T Masters, Alexandra I Barsdorf, Almasa Bass, Glenn Pixton, Jacquelyn G Wilson, Gernot Wolfram
BACKGROUND: The efficacy of ALO-02, an abuse-deterrent formulation containing extended-release oxycodone and sequestered naltrexone, in the treatment of chronic low back pain (CLBP) was studied in a 12-week randomized controlled trial. Primary efficacy endpoint results have been published previously (Rauck et al., 2015). The current paper focuses on patient-reported outcomes for health-related quality of life (HRQL), work productivity, and activity impairment that were assessed during this study...
October 17, 2017: Health and Quality of Life Outcomes
https://www.readbyqxmd.com/read/29025138/relative-bioavailability-intranasal-abuse-potential-and-safety-of-benzhydrocodone-acetaminophen-compared-with-hydrocodone-bitartrate-acetaminophen-in-recreational-drug-abusers
#2
Sven M Guenther, Travis C Mickle, Andrew C Barrett, Kathryn Ann Roupe, Jing Zhou, Vincent Lam
Objectives: Benzhydrocodone is a hydrocodone prodrug that has been combined with acetaminophen (APAP) in a novel immediate-release analgesic. This study evaluated the relative bioavailability, intranasal abuse potential, and safety of benzhydrocodone/APAP compared with commercially available hydrocodone bitartrate (HB)/APAP. Design: Single-center, randomized, double-blind, double-dummy, two-part study comprising a Dose Selection (Part A) phase and a Main Study (Part B) phase...
August 25, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/29025056/adf-abuse-deterrent-formulation-or-another-disillusioned-formulation
#3
Abigail Brooks, Courtney Kominek
No abstract text is available yet for this article.
September 7, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/29024092/pharmaceutical-opioid-use-and-harm-in-australia-the-need-for-proactive-and-preventative-responses
#4
Briony Larance, Louisa Degenhardt, Amy Peacock, Natasa Gisev, Richard Mattick, Samantha Colledge, Gabrielle Campbell
There are parallels between the North American experience of escalating pharmaceutical opioid utilisation and harm and the trends being observed in Australia. In Australia, opioid utilisation has increased dramatically over the past two decades. There have been significant shifts away from the predominant prescribing of 'weak' and short-acting opioids, to 'strong' and long-acting opioids, for an increasing range of chronic pain indications. In concordance with escalating use, Australia is experiencing increases in opioid-related hospital admissions and overdose, as well as opioid dependence and treatment seeking...
October 12, 2017: Drug and Alcohol Review
https://www.readbyqxmd.com/read/29016905/relative-abuse-of-crush-resistant-prescription-opioid-tablets-via-alternative-oral-modes-of-administration
#5
Stephen F Butler, Ryan A Black, Alison B Fleming
Objective: Some crush-resistant tablet formulations (CRTs) reduce prescription opioid abuse by nonoral routes of administration (ROAs), especially insufflation and injection, while oral abuse increases. Oral abuse involving product manipulation vs swallowing whole for CRTs and comparators was examined. Methods: Abuse by oral modes of administration (e.g., swallowing whole, chewing, dissolving in the mouth), was examined using the ASI-MV, a computerized, clinical interview for adults in substance abuse treatment from January 2009 to March 2015...
July 8, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/29016880/evaluation-of-the-relative-intranasal-abuse-potential-of-a-hydrocodone-extended-release-tablet-formulated-with-abuse-deterrence-technology-in-nondependent-recreational-opioid-users
#6
Mary Bond, Kerri A Schoedel, Laura Rabinovich-Guilatt, Maciej Gasior, William Tracewell, Richard Malamut, Yuju Ma, Lynn R Webster
Objective: To assess the intranasal abuse potential of hydrocodone extended-release (ER) tablets developed with CIMA Abuse-Deterrence Technology compared with hydrocodone powder and hydrocodone bitartrate ER capsules (Zohydro ER, original formulation [HYD-OF]). Design: Single-dose, randomized, double-blind, quadruple-dummy, active- and placebo-controlled, crossover study. Setting: One US site. Subjects: Healthy, adult, nondependent, recreational opioid users...
June 14, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/28968188/the-opioid-epidemic-crisis-and-solutions
#7
Phil Skolnick
The widespread abuse of prescription opioids and a dramatic increase in the availability of illicit opioids have created what is commonly referred to as the opioid epidemic. The magnitude of this epidemic is startling: About 4% of the adult US population misuses prescription opioids, and in 2015, more than 33,000 deaths were attributable to overdose with licit and illicit opioids. Increasing the availability of medication-assisted treatments (such as buprenorphine and naltrexone), the use of abuse-deterrent formulations, and the adoption of US Centers for Disease Control and Prevention prescribing guidelines all constitute short-term approaches to quell this epidemic...
October 2, 2017: Annual Review of Pharmacology and Toxicology
https://www.readbyqxmd.com/read/28948482/effect-of-food-on-the-pharmacokinetics-of-single-and-multiple-dose-hydrocodone-extended-release-in-healthy-subjects
#8
Mary Bond, Laura Rabinovich-Guilatt, Sally Selim, Mona Darwish, William Tracewell, Philmore Robertson, Ronghua Yang, Richard Malamut, Philippe Colucci, Murray P Ducharme, Ofer Spiegelstein
BACKGROUND AND OBJECTIVES: Food intake can alter the pharmacokinetics of certain medications, including changes in their oral bioavailability, which is of particular concern for extended-release (ER) opioids because of the high drug loads. Two randomized, open-label studies assessed the effect of food on the pharmacokinetics of single and multiple doses of hydrocodone ER formulated with CIMA(®) Abuse-Deterrence Technology. METHODS: Healthy subjects in fed and fasted states received single 90-mg doses of hydrocodone ER (Studies 1 and 2) or multiple doses of hydrocodone ER (45 mg twice daily on days 2-3, 60 mg twice daily on days 4-5, 90 mg twice daily on days 6-10, and 90 mg once in the morning on day 11) (Study 2)...
September 25, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28944983/oral-prolonged-release-oxycodone-naloxone-for-managing-pain-and-opioid-induced-constipation-a-review-of-the-evidence
#9
REVIEW
Bart J Morlion, Stefan A Mueller-Lissner, Renato Vellucci, Wojciech Leppert, Benoît C Coffin, Sara L Dickerson, Tony O'Brien
BACKGROUND: Opioids provide effective relief from moderate-to-severe pain and should be prescribed as part of a multifaceted approach to pain management when other treatments have failed. Fixed-dose oxycodone/naloxone prolonged-release tablets (OXN PR) were designed to address the opioid class effect of opioid-induced constipation (OIC) by combining the analgesic efficacy of oxycodone with the opioid receptor antagonist, naloxone, which has negligible systemic availability when administered orally...
September 25, 2017: Pain Practice: the Official Journal of World Institute of Pain
https://www.readbyqxmd.com/read/28940174/in-vitro-drug-release-after-crushing-evaluation-of-xtampza-%C3%A2-er-and-other-er-opioid-formulations
#10
Stephen P Mayock, Said Saim, Alison B Fleming
BACKGROUND AND OBJECTIVE: Extended-release (ER) opioids are associated with high rates of abuse. Recreational opioid users often manipulate ER formulations to achieve a high plasma concentration in a short amount of time, resulting in a more rapid and intense high. Patients may also manipulate ER tablets to facilitate swallowing, without recognizing that manipulation could increase release rate. The goal of this study was to assess the ability of oxycodone DETERx (Xtampza(®) ER, Collegium Pharmaceutical, Inc...
September 22, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28833803/important-statistical-considerations-in-the-evaluation-of-post-market-studies-to-assess-whether-opioids-with-abuse-deterrent-properties-result-in-reduced-abuse-in-the-community
#11
Kunthel By, Jana K McAninch, Stephine L Keeton, Alex Secora, Cynthia J Kornegay, Catherine S Hwang, Thomas Ly, Mark S Levenson
PURPOSE: Abuse, misuse, addiction, overdose, and death associated with non-medical use of prescription opioids have become a serious public health concern. Reformulation of these products with abuse-deterrent properties is one approach for addressing this problem. FDA has approved several extended-release opioid analgesics with abuse-deterrent labeling, the bases of which come from pre-market studies. As all opioid analgesics must be capable of delivering the opioid in order to reduce pain, abuse-deterrent properties do not prevent abuse, nor do pre-market evaluations ensure that there will be reduced abuse in the community...
August 23, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28830383/midwives-and-patients-perspectives-on-disrespect-and-abuse-during-labor-and-delivery-care-in-ethiopia-a-qualitative-study
#12
Sahai Burrowes, Sarah Jane Holcombe, Dube Jara, Danielle Carter, Katheryn Smith
BACKGROUND: It is increasingly recognized that disrespect and abuse of women during labor and delivery is a violation of a woman's rights and a deterrent to the use of life-saving, facility-based labor and delivery services. In Ethiopia, rates of skilled birth attendance are still only 28% despite a recent dramatic national scale up in the numbers of trained providers and facilities. Concerns have been raised that womens' perceptions of poor quality of care and fear of mistreatment might contribute to this low utilization...
August 22, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28829526/clinical-relevance-of-the-pharmacokinetic-characteristics-of-an-abuse-deterrent-extended-release-injection-molded-morphine-tablet
#13
Jeffrey M Dayno, Gwendolyn Niebler, John Lawler, Torben Elhauge, Karsten Lindhardt
OBJECTIVE: To characterize the pharmacokinetics (PK) and in vitro alcohol dissolution characteristics of extended-release (ER), injection-molded (IM) morphine tablets with abuse-deterrent (AD) features (morphine-ADER-IMT). DESIGN: In vivo, in vitro, and in silico studies were conducted. A randomized, two-cohort study evaluated the bioequivalence of morphine-ADER-IMT (60 mg) to morphine ER (60 mg; MS Contin®; Purdue Pharma LP, Stamford, CT) and characterized the effect of food on the PK profile of morphine-ADER-IMT...
March 2017: Journal of Opioid Management
https://www.readbyqxmd.com/read/28794653/real-world-utilization-of-once-daily-extended-release-abuse-deterrent-formulation-of-hydrocodone-a-comparison-with-the-pre-approval-randomized-clinical-trials
#14
Louise Taber, T Christopher Bond, Xuezhe Wang, Aditi Kadakia, Tracy J Mayne
BACKGROUND AND OBJECTIVE: Hydrocodone bitartrate extended release (Hysingla(®) ER, HYD) was previously studied in a 12-week randomized, double-blind, placebo-controlled trial and a 52-week open-label safety study. Both of these preapproval studies allowed dose titration to efficacy. The purpose of the present analysis was to compare dosing and utilization patterns in these previous clinical trials with real-world data (RWD) usage in a retrospective claim analysis performed 12-14 months post approval in the US...
2017: Journal of Pain Research
https://www.readbyqxmd.com/read/28772173/heroin-use-onset-among-nonmedical-prescription-opioid-users-in-the-club-scene
#15
Hilary L Surratt, Steven P Kurtz, Mance Buttram, Maria A Levi-Minzi, Maria E Pagano, Theodore J Cicero
BACKGROUND: Nonmedical prescription opioid use (NMPOU) is well documented among participants in the club scene, yet prior studies have not examined transition to heroin use. We prospectively examined heroin initiation among a sample of young adults with drug involvement associated with participation in the club scene, to understand factors that influence transition from NMPOU to heroin and to identify opportunities for intervention. METHODS: Data were drawn from a randomized trial that enrolled 750 Miami-based club and prescription drug users through respondent driven sampling, and tested the efficacy of assessment interventions in reducing risk...
October 1, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28771942/patterns-of-abuse-and-routes-of-administration-for-immediate-release-hydrocodone-combination-products
#16
Theresa A Cassidy, Natasha Oyedele, Travis C Mickle, Sven Guenther, Simon H Budman
PURPOSE: Prescriptions for hydrocodone immediate-release (IR) combination products have recently decreased, yet they represent the majority of opioid prescriptions dispensed and are commonly abused analgesics among both adults and adolescents. Little data exist to understand the contribution of IR products to the problem of prescription opioid abuse. This study aimed to better understand abuse patterns for hydrocodone IR combination products among adult and adolescent substance abusers...
September 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28726042/reproductive-desires-and-considerations-of-hiv-positive-men-in-heterosexual-relationships-in-new-york-city
#17
Karolynn Siegel, Étienne Meunier, Jack Ume Tocco, Helen-Maria Lekas
The reproductive desires of HIV-positive men have been investigated far less than those of HIV-positive women, especially in the US. This qualitative study of a sample of 94 HIV-positive men in New York City who were in a relationship with a woman of reproductive age examined their reasons for wanting a child as well as the conditions under which they would feel ready to attempt conception. Participants felt a child would make them feel normal, give meaning to their lives, or make others in their life happy...
July 19, 2017: AIDS and Behavior
https://www.readbyqxmd.com/read/28700587/community-and-health-system-intervention-to-reduce-disrespect-and-abuse-during-childbirth-in-tanga-region-tanzania-a-comparative-before-and-after-study
#18
Stephanie A Kujawski, Lynn P Freedman, Kate Ramsey, Godfrey Mbaruku, Selemani Mbuyita, Wema Moyo, Margaret E Kruk
BACKGROUND: Abusive treatment of women during childbirth has been documented in low-resource countries and is a deterrent to facility utilization for delivery. Evidence for interventions to address women's poor experience is scant. We assessed a participatory community and health system intervention to reduce the prevalence of disrespect and abuse during childbirth in Tanzania. METHODS AND FINDINGS: We used a comparative before-and-after evaluation design to test the combined intervention to reduce disrespect and abuse...
July 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28653782/changes-in-drug-use-patterns-reported-on-the-web-after-the-introduction-of-adf-oxycontin-findings-from-the-researched-abuse-diversion-and-addiction-related-surveillance-radars-system-web-monitoring-program
#19
Suzanne K Vosburg, Colleen Haynes, Andrea Besharat, Jody L Green
This qualitative study summarizes information that individuals shared online about use of OxyContin following the August 2010 introduction of the abuse deterrent formulation (ADF). PURPOSE: The primary objective was to study online posts that endorsed continued use of OxyContin or a switch from OxyContin to another formulation of oxycodone or another substance altogether following the introduction of the ADF. A secondary objective was to determine whether posts revealed that the ADF led to cessation of OxyContin use...
September 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28640970/prevalence-of-new-psychoactive-substances-and-prescription-drugs-in-the-belgian-driving-under-the-influence-of-drugs-population
#20
S M R Wille, C Richeval, M Nachon-Phanithavong, J M Gaulier, V Di Fazio, L Humbert, N Samyn, D Allorge
Driving under the influence of drugs (DUID) is a worldwide problem. Several countries have adopted DUID legislations which prove their deterrent effect and impact on road safety. However, the use of new psychoactive substances (NPS) and prescription drugs is not known, as the applied roadside screening tests have not yet been adapted for these compounds. In this study, 558 blood samples obtained during roadside controls in Belgium (January to August 2015) after a positive Drugwipe 5S® test and 199 oral fluid (OF) samples obtained from negatively screened test pads were analyzed...
June 22, 2017: Drug Testing and Analysis
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