Linked Life Data

19944650

Source:http://linkedlifedata.com/resource/pubmed/id/19944650

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2010-3-30
pubmed:abstractText
ALO-01 (EMBEDA [morphine sulfate and naltrexone hydrochloride] extended-release capsules [King Pharmaceuticals, Inc, Bridgewater, NJ]), indicated for chronic moderate-to-severe pain, is designed to release naltrexone upon tampering (eg, by crushing), reducing morphine-induced subjective effects. This multicenter, randomized, double-blind, crossover study assessed pharmacokinetics, efficacy, and safety of ALO-01 and compared them with extended-release morphine sulfate (ERMS, KADIAN [morphine sulfate extended-release] capsules [Actavis US, Morristown, NJ]) in adults (N = 113) with osteoarthritis pain. Study periods included washout until pain flare (intensity > or =5, 0 to 10; 0 = no pain, 10 = worst pain); dose titration with ERMS (20 to 160mg BID); and randomization to 2 (crossover) 14-day treatment periods with ERMS or ALO-01, separated by 7 days of open-label ERMS. Assessments included pharmacokinetics (morphine, naltrexone), pain scores (0 to 10), Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; Patient Global Assessment of Medication (1 to 5; poor to excellent). Mean score at pain flare was 7.1. Morphine exposure from both formulations at steady state was similar. Plasma naltrexone concentrations were below limit-of-quantification for most patients and, when present, did not impact pain scores. During treatment, mean pain intensity (day 14: ERMS, 2.4; ALO-01, 2.3, P = .31), WOMAC change-from-baseline (mean pain, physical function, composite scores), and adverse event frequency were similar. ALO-01 and ERMS provided similar relief of osteoarthritis pain. PERSPECTIVE: We present data demonstrating that ALO-01 has steady-state morphine exposure, efficacy, and safety similar to marketed ERMS capsules. Results highlight the potential for morphine in ALO-01 to manage moderate-to-severe osteoarthritis pain, while the sequestered naltrexone does not interfere with efficacy.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Apr
pubmed:issn
1528-8447
pubmed:author
pubmed:copyrightInfo
Copyright 2010 American Pain Society. Published by Elsevier Inc. All rights reserved.
pubmed:issnType
Electronic
pubmed:volume
11
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
303-11
pubmed:meshHeading
pubmed-meshheading:19944650-Adult, pubmed-meshheading:19944650-Aged, pubmed-meshheading:19944650-Aged, 80 and over, pubmed-meshheading:19944650-Analgesics, Opioid, pubmed-meshheading:19944650-Chronic Disease, pubmed-meshheading:19944650-Cross-Over Studies, pubmed-meshheading:19944650-Double-Blind Method, pubmed-meshheading:19944650-Drug Combinations, pubmed-meshheading:19944650-Female, pubmed-meshheading:19944650-Humans, pubmed-meshheading:19944650-Male, pubmed-meshheading:19944650-Middle Aged, pubmed-meshheading:19944650-Morphine, pubmed-meshheading:19944650-Morphine Dependence, pubmed-meshheading:19944650-Naltrexone, pubmed-meshheading:19944650-Narcotic Antagonists, pubmed-meshheading:19944650-Osteoarthritis, Hip, pubmed-meshheading:19944650-Osteoarthritis, Knee, pubmed-meshheading:19944650-Pain Measurement, pubmed-meshheading:19944650-Street Drugs, pubmed-meshheading:19944650-Treatment Outcome
pubmed:year
2010
pubmed:articleTitle
ALO-01 (morphine sulfate and naltrexone hydrochloride) extended-release capsules in the treatment of chronic pain of osteoarthritis of the hip or knee: pharmacokinetics, efficacy, and safety.
pubmed:affiliation
Tufts University School of Medicine, Boston, Massachusetts; Analgesic Research, Needham, MA 02494, USA. nkatz@analgesicresearch.com
pubmed:publicationType
Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study, Clinical Trial, Phase II