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https://www.readbyqxmd.com/read/27915497/current-and-future-development-of-extended-release-abuse-deterrent-opioid-formulations-in-the-united-states
#1
Lynn R Webster, John Markman, Edward J Cone, Gwendolyn Niebler
Prescription opioid misuse and abuse in the United States (US) is epidemic and is a major burden on healthcare resources and costs to society. The need to significantly reduce the risks of prescription opioid misuse and abuse must be balanced with the important needs of patients with chronic pain who may benefit from treatment with opioids. The use of abuse-deterrent formulations (ADFs) of prescription opioids is one approach that could reduce the risk of prescription opioid abuse and misuse while maintaining access to opioids...
December 3, 2016: Postgraduate Medicine
https://www.readbyqxmd.com/read/27897471/use-of-risk-mitigation-practices-by-family-nurse-practitioners-prescribing-opioids-for-the-management-of-chronic-non-malignant-pain
#2
Sahil Chaudhary, Peggy Compton
BACKGROUND: Ongoing opioid analgesic use in patients suffering from chronic non-malignant pain (CNMP) has been associated with the development of opioid misuse, abuse, addiction, and overdose. To prevent these adverse outcomes, it is important that family nurse practitioners (FNPs) implement recommended risk mitigation practices (RMPs) when treating CNMP patients with opioids. METHODS: A national sample of 856 FNPs was invited to answer an online survey about their utilization of opioids and RMPs in treating CNMP...
November 29, 2016: Substance Abuse
https://www.readbyqxmd.com/read/27873179/oxycodone-deterx-%C3%A2-a-novel-abuse-deterrent-extended-release-analgesic-option-for-the-treatment-of-patients-with-chronic-pain
#3
REVIEW
Jeff Gudin
BACKGROUND: Extended-release (ER) opioid analgesics are commonly used to provide safe and effective pain relief to treat pain severe enough to require around-the-clock, long-term dosing. These ER opioid formulations usually contain more drug per dosage unit than immediate-release (IR) agents, and therefore bring with them challenges related to both opioid abuse and misuse, often through manipulation of the dosage form. Oxycodone DETERx(®) (Xtampza(®) ER, Collegium Pharmaceutical, Inc...
December 2016: Pain and Therapy
https://www.readbyqxmd.com/read/27832472/oxycodone-deterx-%C3%A2-er-capsules-a-review-in-severe-chronic-pain
#4
Yvette N Lamb, Karly P Garnock-Jones, Susan J Keam
Oxycodone DETERx (®) extended-release (ER) capsules (Xtampza(®) ER), an abuse-deterrent formulation of oxycodone as the myristate salt, are approved in the USA for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. This narrative review discusses the clinical efficacy and tolerability of the oxycodone DETERx (®) ER capsule formulation in the management of severe pain, and provides an overview of pharmacokinetics, abuse-deterrent properties and alternative administration options...
November 10, 2016: Drugs
https://www.readbyqxmd.com/read/27718163/hydrocodone-bitartrate-er-hysingla-%C3%A2-er-a-review-in-chronic-pain
#5
Sohita Dhillon
Hydrocodone bitartrate extended-release (Hysingla(®) ER; referred to hereafter as hydrocodone ER) was the first single-entity hydrocodone formulation recognized by the US FDA as having abuse-deterrent properties. It is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Once-daily oral hydrocodone ER provides consistent plasma hydrocodone concentrations and sustained analgesia over the 24-h dosing interval...
November 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27716575/sustained-reduction-of-diversion-and-abuse-after-introduction-of-an-abuse-deterrent-formulation-of-extended-release-oxycodone
#6
Stevan Geoffrey Severtson, Matthew S Ellis, Steven P Kurtz, Andrew Rosenblum, Theodore J Cicero, Mark W Parrino, Michael K Gilbert, Mance E Buttram, Nabarun Dasgupta, Becki BucherBartelson, Jody L Green, Richard C Dart
BACKGROUND: The development of abuse deterrent formulations is one strategy for reducing prescription opioid misuse and abuse. A putative abuse deterrent formulation of oxycodone extended release (OxyContin(®)) was introduced in 2010. Early reports demonstrated reduced abuse and diversion, however, an analysis of social media found 32 feasible methods to circumvent the abuse deterrent mechanism. We measured trends of diversion, abuse and street price of OxyContin to assess the durability of the initial reduction in abuse...
November 1, 2016: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/27673203/poster-457-bioequivalence-and-food-effect-of-a-novel-abuse-deterrent-ad-extended-release-er-morphine-product-candidate-compared-with-a-currently-available-non-ad-er-morphine-product
#7
Jeffrey M Dayno, John Lawler, Gwendolyn Niebler, Karsten Lindhardt
No abstract text is available yet for this article.
September 2016: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/27673177/poster-427-pharmacodynamic-effects-from-a-category-3-intranasal-human-abuse-potential-study-of-an-abuse-deterrent-extended-release-morphine-product-candidate-in-nondependent-recreational-opioid-users
#8
Lynn R Webster, Michael D Smith, John Lawler, Karsten Lindhardt, Jeffrey M Dayno
No abstract text is available yet for this article.
September 2016: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/27673172/poster-420-pharmacodynamic-effects-from-a-category-3-oral-human-abuse-potential-study-of-an-abuse-deterrent-extended-release-morphine-product-candidate-in-nondependent-recreational-opioid-users
#9
Michael D Smith, Lynn R Webster, John Lawler, Karsten Lindhardt, Jeffrey M Dayno
No abstract text is available yet for this article.
September 2016: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/27673168/poster-416-dissolution-studies-in-the-presence-of-alcohol-with-an-abuse-deterrent-extended-release-morphine-product-candidate
#10
Torben Elhauge, Lene Kristensen, Jeffrey M Dayno, Karsten Lindhardt
No abstract text is available yet for this article.
September 2016: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/27669664/oral-human-abuse-potential-of-oxycodone-deterx-%C3%A2-xtampza-%C3%A2-er
#11
Ernest A Kopecky, Alison B Fleming, Naama Levy-Cooperman, Melinda O'Connor, Edward Sellers
Oxycodone DETERx(®) (Collegium Pharmaceutical Inc, Canton, MA) is an extended-release, microsphere-in-capsule, abuse-deterrent formulation designed to retain its extended-release properties after tampering (eg, chewing/crushing). This randomized, double-blind, placebo-controlled, triple-dummy study evaluated the oral abuse potential of intact and chewed oxycodone DETERx capsules compared with crushed immediate-release oxycodone. Subjects with a history of recreational opioid use who were nondependent/nontolerant to opioids were enrolled...
September 27, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27668546/an-abuse-deterrent-microsphere-in-capsule-formulation-of-extended-release-oxycodone-alternative-modes-of-administration-to-facilitate-pain-management-in-patients-with-dysphagia
#12
Bill H McCarberg, Ernest A Kopecky, Melinda O'Connor, Ann Marseilles, Ravi K Varanasi, Christy Thompson, Alison B Fleming
BACKGROUND: Patients with chronic pain may experience difficulty swallowing, in part due to worsening disease, comorbid conditions, iatrogenic etiology, or age. Patients or caregivers may manipulate extended-release (ER) opioid formulations to facilitate oral dosing due to a lack of therapeutic options that allow for sprinkle or enteral feeding tube administration. If crushed or broken, current oral ER opioids can be associated with adverse sequelae, including risk of potentially fatal overdose...
September 26, 2016: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/27651514/oral-abuse-potential-pharmacokinetics-and-safety-of-once-daily-single-entity-extended-release-hydrocodone-hyd-in-recreational-opioid-users
#13
Stephen C Harris, Alessandra Cipriano, Ram P Kapil, Naama Levy-Cooperman, Salvatore V Colucci, Pierre Geoffroy, Talar Hopyan
OBJECTIVES:  A once-daily, extended-release hydrocodone bitartrate tablet with abuse-deterrent properties (Hysingla ER [HYD]) is available for the treatment of chronic pain in appropriate patients. This study evaluated the oral abuse potential and pharmacokinetics (PK) of HYD intact, chewed, or milled to fine particles in comparison with hydrocodone solution or placebo. DESIGN:  Single-center, double-blind, randomized, five-period, five-treatment crossover study...
September 19, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/27651510/human-abuse-potential-of-an-abuse-deterrent-ad-extended-release-er-morphine-product-candidate-morphine-ader-injection-molded-tablets-vs-extended-release-morphine-administered-intranasally-in-nondependent-recreational-opioid-users
#14
Lynn R Webster, Michael D Smith, John Lawler, Karsten Lindhardt, Jeffrey M Dayno
: OBJECTIVE : To compare the relative human abuse potential after insufflation of manipulated morphine abuse-deterrent, extended-release injection-molded tablets (morphine-ADER-IMT) with that of marketed morphine ER tablets. METHODS : A randomized, double-blind, double-dummy, active- and placebo-controlled five-way crossover study was performed with adult volunteers who were experienced, nondependent, recreational opioid users. After intranasal (IN) administration of manipulated high-volume (HV) morphine-ADER-IMT (60 mg), participants were randomized (1:1:1:1) to receive IN manipulated low-volume (LV) morphine ER (60 mg), IN manipulated LV morphine-ADER-IMT, intact oral morphine-ADER-IMT (60 mg), and placebo in crossover fashion...
September 20, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/27651506/a-randomized-double-blind-double-dummy-placebo-controlled-intranasal-drug-liking-study-on-a-novel-abuse-deterrent-formulation-of-morphine-morphine-arer
#15
Lynn R Webster, Carmela Pantaleon, Manish S Shah, Ray DiFalco, Matthew Iverson, Michael D Smith, Eric R Kinzler, Stefan Aigner
OBJECTIVE:  Misuse and abuse of prescription opioids remains a major healthcare concern despite considerable efforts to increase public awareness. Abuse-deterrent formulations of prescription opioids are designed to reduce intentional misuse, abuse, and prescription opioid-related death. A novel extended-release (ER) formulation of morphine (Morphine ARER; MorphaBond™) resists physical manipulation and retains the drug's ER characteristics, even if attempts are made to manipulate the formulation...
September 20, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/27633773/human-abuse-potential-of-an-abuse-deterrent-ad-extended-release-er-morphine-product-candidate-morphine-ader-injection-molded-tablets-versus-extended-release-morphine-administered-orally-in-nondependent-recreational-opioid-users
#16
Michael D Smith, Lynn R Webster, John Lawler, Karsten Lindhardt, Jeffrey M Dayno
OBJECTIVE: To compare the relative human abuse potential of intact and manipulated morphine abuse-deterrent, extended-release injection-molded tablets (morphine-ADER-IMT) with that of marketed morphine sulfate ER tablets METHODS: This randomized, double-blind, triple-dummy, active- and placebo-controlled, 4-way crossover, single-center study included adult volunteers who were experienced, nondependent, recreational opioid users. Participants were randomized 1:1:1:1 to placebo, morphine-ADER-IMT (60 mg, intact), morphine-ADER-IMT (60 mg, manipulated), and morphine ER (60 mg, manipulated) and received 1 dose of each oral agent in crossover fashion, separated by ≥5 days...
September 15, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/27600925/striving-for-consensus-on-approaches-to-category-1-testing-of-abuse-deterrent-formulations-of-opioids-discussions-from-the-first-category-1-focus-group-meeting
#17
EDITORIAL
Edward J Cone, Marta Sokolowska, Karsten Lindhardt
No abstract text is available yet for this article.
September 2016: Pain Practice: the Official Journal of World Institute of Pain
https://www.readbyqxmd.com/read/27599334/a-new-abuse-deterrent-opioid-xtampza-er
#18
(no author information available yet)
No abstract text is available yet for this article.
September 6, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27550954/abuse-potential-study-of-alo-02-extended-release-oxycodone-surrounding-sequestered-naltrexone-compared-with-immediate-release-oxycodone-administered-orally-to-nondependent-recreational-opioid-users
#19
Beatrice Stenik, Almasa Bass, Candace Bramson, Naama Levy-Cooperman, Bimal Malhotra, Kyle Matschke, Pierre Geoffroy, Kenneth W Sommerville, Gernot Wolfram
OBJECTIVE: To evaluate the abuse potential of ALO-02, an abuse-deterrent formulation comprising pellets of extended-release oxycodone hydrochloride surrounding sequestered naltrexone hydrochloride. DESIGN: Randomized, double-blind, placebo-/active-controlled, 6-way crossover study, with naloxone challenge, drug discrimination, and treatment phases. SUBJECTS: Nondependent, recreational opioid users. METHODS: Oral administration of crushed and intact ALO-02, crushed immediate-release (IR) oxycodone, and placebo...
August 22, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/27546356/parachuting-a-dangerous-trend-in-recreational-psychoactive-substance-delivery
#20
David Boels, Marie Grall-Bronnec, Marylène Guerlais, Gael Le Roux, Andrew Spiers, Marie Gerardin, Hélène Lomenech, Marie Bretaudeau-Deguigne, Amélie Daveluy, Alain Turcant, Pascale Jolliet, Caroline Victorri-Vigneau
INTRODUCTION: Medicine diversion for recreational use is a constant concern for health authorities. Parachuting, also refered to as bombing, is used in order to increase the expected effect, to accelerate time-to-onset and to create mixtures of medicines and substances. Aeras covered: Firstly, we analyzed all available scientific literature (PRISMA) and internet forums without any limiting timeframe. Secondly, we collected cases of parachuting reported in the west of France by the addictovigilance and poison control centres...
August 22, 2016: Expert Opinion on Drug Delivery
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