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Oxycodone ER

Sebastiano Mercadante
As a consequence of greater prescription opioid utilization, there has been the parallel increase in misuse, abuse, and overdose, which are serious risks. Associated new formulations may be safer. Areas covered: The introduction of abuse-deterrent opioid formulations and continuous programs to improve opioid prescribing practices may limit the opioid abuse and its consequences. Oxycodone extended release capsules are an extended-release (ER), microsphere-in-capsule abuse-deterrent-formulation designed to retain its extended-release properties following tampering or misuse (e...
March 10, 2017: Expert Review of Neurotherapeutics
Kathrin Jobski, Bianca Kollhorst, Edeltraut Garbe, Tania Schink
INTRODUCTION: In Germany, an extended-release (ER) combination of the high-potency opioid (HPO) oxycodone and the antagonist naloxone was approved in 2006. In recent years, the cardio- and cerebrovascular safety of opioid antagonists and of opioids themselves has been discussed. OBJECTIVES: The objective of this study was to estimate the risk of major ischemic cardio- and cerebrovascular events in patients receiving ER oxycodone-naloxone compared with those receiving other ER HPOs...
February 13, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
E Kopecky, B Vaughn, M O'Connor
No abstract text is available yet for this article.
April 2016: Journal of Pain: Official Journal of the American Pain Society
Akhila Sunkepally Reddy, Eden Mae Rodriguez, Eduardo Bruera
217 Background: Uncontrolled pain is one of the main fears for patients with cancer and their families. Opioid analgesics are highly effective agents, but the choice of type, route, and dose needs to be personalized. The highly cost of some of them can make it difficult for patients to received adequate pain control without appropriate insurance coverage. There is a lack of information regarding the frequency of denials or heavy copayments by insurers. METHODS: We evaluated 143 continuous opioid test claims for prescriptions by our palliative care providers for opioids other than morphine, including transdermal fentanyl, extended release oxycodone, hydromorphone and oxymorphone...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Paul M Coplan, Nelson E Sessler, Venkatesh Harikrishnan, Richa Singh, Charles Perkel
OBJECTIVE: Prescription opioid related abuse, suicide and death are significant public health problems. This study compares rates of poison center calls categorized as intentional abuse, suspected suicidal intent or fatality for the 7-day buprenorphine transdermal system/patch (BTDS) with other extended-release and long-acting (ER/LA) opioids indicated for chronic pain. METHODS: Retrospective 24-month cohort study using National Poison Data System data from July 2012 through June 2014...
January 2017: Postgraduate Medicine
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
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...
December 2016: Drugs
Ernest A Kopecky, Alison B Fleming, Naama Levy-Cooperman, Melinda O'Connor, Edward M Sellers
Oxycodone DETERx(®) (Collegium Pharmaceutical Inc, Canton, Massachusetts) 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...
April 2017: Journal of Clinical Pharmacology
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
Howard D Chilcoat, Paul M Coplan, Venkatesh Harikrishnan, Louis Alexander
BACKGROUND: Doctor-shopping (obtaining prescriptions from multiple prescribers/pharmacies) for opioid analgesics produces a supply for diversion and abuse, and represents a major public health issue. METHODS: An open cohort study assessed changes in doctor-shopping in the U.S. for a brand extended release (ER) oxycodone product (OxyContin) and comparator opioids before (July, 2009 to June, 2010) versus after (January, 2011 to June, 2013) introduction of reformulated brand ER oxycodone with abuse-deterrent properties, using IMS LRx longitudinal data covering >150 million patients and 65% of retail U...
August 1, 2016: Drug and Alcohol Dependence
Theodore J Cicero, Matthew S Ellis, Zachary A Kasper
The introduction of extended-release opioid analgesics helped initiate an epidemic of prescription opioid abuse in the United States. To make access to the drug by crushing or dissolution more difficult, abuse-deterrent formulations (ADFs) of OxyContin (Purdue Pharma, Stamford, CT) and Opana ER (Endo Pharmaceuticals Inc., Malvern, PA), which use the same foundation technology (Intac, Grunenthal, Aachen, Germany), were introduced in 2010 and 2012, respectively. To examine their relative effectiveness, we used a structured survey of 12,124 individuals entering treatment for opioid use disorder followed by a more focused online survey with a subset of these patients (N = 129) using both structured and open-ended questions...
June 2016: Pain
Kuan Gandelman, Michael Lamson, Candace Bramson, Kyle Matschke, Joanne Salageanu, Bimal Malhotra
ALO-02 capsules (ALO-02) contain pellets that consist of extended-release oxycodone that surrounds sequestered naltrexone. The primary objective was to characterize the pharmacokinetics (PK) of oxycodone following single- and multiple-dose oral administration of ALO-02 40 mg BID in healthy volunteers. Secondary objectives were to characterize (1) the PK of oxycodone following single- and multiple-dose administration of a comparator OxyContin (OXY-ER) 40 mg BID as well as an alternate regimen of ALO-02 80 mg QD, and (2) the safety and tolerability assessments...
September 2015: Clinical Pharmacology in Drug Development
Srinivas Nalamachu, Ernest A Kopecky, Robert Taylor, Ben Vaughn, Melinda O'Connor
BACKGROUND: Abuse deterrent formulations (ADF) are designed to prevent the misuse of opioids by tampering (e.g. physical and chemical manipulation) in order to ingest the opioid in a manner other than intended. Extended-release (ER) formulations are formulated with a larger drug load than immediate-release (IR) formulations, which makes ER opioids more desirable to drug abusers than I.R. formulations. ADFs, therefore, are particularly useful with ER opioid agents, which are designed to produce consistent analgesia over prolonged dosing intervals...
July 2016: Current Medical Research and Opinion
Alison B Fleming, Todd A Scungio, Michael P Grima, Stephen P Mayock
OBJECTIVE: Abuse of prescription analgesics is a well-recognized problem, with nearly 2 million people aged 12 years or older initiating nonmedical use of pain relievers in 2012. The prevalence of opioid abuse via intravenous (IV) injection has led to the development of dosage forms designed to deter abuse using different inactive ingredients and formulation strategies. This study evaluated the IV abuse potential for a novel, microsphere-encapsulated abuse-deterrent formulation of oxycodone, Xtampza™ ER (referred to as "oxycodone DETERx")...
January 2016: Journal of Opioid Management
Nobushige Yabe, Shinji Murai, Yoko Harada, Takahiro Yokose, Takamichi Yokoe, Ippei Oto, Takahisa Yoshikawa, Kenjiro Kitasato, Hirotomo Shimizu, Hiromitsu Jinno, Yuko Kitagawa
A 51-year-old woman had previously received treatment for breast cancer at another hospital but had refused early and aggressive treatment. Therefore, she was treated with symptomatic therapy. As her disease progressed, the patient wished to receive palliative care, and was transferred to a palliative care hospital. However, based on her general condition, it was determined that aggressive treatment should not be abandoned, and she was referred to our hospital for treatment. During her initial visit, the patient was found to have left breast cancer with chest wall invasion, right breast metastasis, multiple liver and lung metastases, left pleural effusion accompanied by pleural dissemination, and left upper limb edema...
November 2015: Gan to Kagaku Ryoho. Cancer & Chemotherapy
David M Biondi, Jim Xiang, Mila Etropolski, Bruce Moskovitz
OBJECTIVE: Management of chronic pain in elderly adult patients is often complicated by analgesic medication-related side effects. This post hoc analysis of pooled data evaluated the tolerability and analgesic efficacy of tapentadol extended release (ER) compared with oxycodone controlled release (CR) in elderly adult patients (≥ 75 years of age) with moderate to severe, chronic osteoarthritis knee or low back pain. METHODS: Data were pooled from three similarly designed, randomized, doubleblind, placebo- and active-controlled, phase 3 studies of tapentadol ER for moderate to severe, chronic osteoarthritis knee (NCT00421928, NCT00486811) or low back (NCT00449176) pain, and data for patients ≥ 75 years of age were evaluated...
September 2015: Journal of Opioid Management
Mary Hanna Bekhit
This article provides a historical and pharmacological overview of a new opioid analgesic that boasts an extended-release (ER) formulation designed to provide both immediate and prolonged analgesia for up to 12 hours in patients who are experiencing acute pain. This novel medication, ER oxycodone/acetaminophen, competes with current US Food and Drug Administration (FDA)-approved opioid formulations available on the market in that it offers two benefits concurrently: a prolonged duration of action, and multimodal analgesia through a combination of an opioid (oxycodone) with a nonopioid component...
2015: Journal of Pain Research
Robert Buynak, Stephen A Rappaport, Kevin Rod, Pierre Arsenault, Fabian Heisig, Christine Rauschkolb, Mila Etropolski
PURPOSE: Tapentadol extended release (ER) has demonstrated efficacy and safety for the management of moderate to severe, chronic pain in adults. This study evaluated the long-term safety and tolerability of tapentadol ER in patients with chronic osteoarthritis or low back pain. METHODS: Patients were enrolled in this 1-year, open-label extension study after completing one of two 15-week, placebo-controlled studies of tapentadol ER and oxycodone controlled release (CR) for osteoarthritis knee pain (NCT00421928) or low back pain (NCT00449176), a 7-week crossover study between tapentadol immediate release and tapentadol ER for low back pain (NCT00594516), or a 1-year safety study of tapentadol ER and oxycodone CR for osteoarthritis or low back pain (NCT00361504)...
November 1, 2015: Clinical Therapeutics
Ryan M Franke, Terri Morton, Krishna Devarakonda
This analysis evaluated the single-dose population pharmacokinetics (PK) of biphasic immediate-release (IR)/extended-release (ER) oxycodone (OC)/acetaminophen (APAP) 7.5/325 mg tablets administered under fasted conditions and the effects of a meal on their single-dose population PK. Data were pooled from four randomized, single-dose crossover trials enrolling healthy adult (18-55 years old) participants (three trials) and nondependent recreational users of prescription opioids (one trial) with a body weight of ≥59 kg...
2015: Drug Design, Development and Therapy
Thomas Barrett, Kenneth Kostenbader, Srinivas Nalamachu, Michael Giuliani, Jim L Young
OBJECTIVES: To characterize the safety of immediate-release (IR)/extended-release (ER) oxycodone (OC)/acetaminophen (APAP). METHODS: Data were assessed from 9 phase 1 trials in healthy volunteers and recreational users of prescription opioids (N = 405), including 5 single-dose and 3 multidose open-label pharmacokinetic studies of IR/ER OC/APAP and active comparators; and 1 randomized, controlled, single-dose human abuse potential (HAP) study comparing IR/ER OC/APAP, IR OC/APAP, and placebo in recreational users of opioids; and 2 phase 3 trials (N = 701) including a 48-hour placebo-controlled safety and efficacy study in patients with moderate to severe postbunionectomy pain with a 14-day open-label safety extension and a long-term (≤ 35 days) open-label safety study in patients with chronic osteoarthritis pain or chronic low back pain...
September 2016: Pain Practice: the Official Journal of World Institute of Pain
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