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

The Journal of Pain : Official Journal of the American Pain Society
Nathaniel KatzJoseph Stauffer

Abstract

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...Continue Reading

References

Jun 1, 1979·The American Journal of Psychiatry·D A Julius
May 1, 1995·Journal of Clinical Pharmacology·R F KaikoR S Sackler
Aug 24, 2004·The Clinical Journal of Pain·San KellerCharles S Cleeland
Apr 4, 2006·Drug and Alcohol Dependence·Curtis WrightJ David Haddox
Jul 11, 2006·Expert Opinion on Drug Delivery·Paul Sloan, Najib Babul
Jan 24, 2007·The Clinical Journal of Pain·Nathaniel P KatzStephen D Lande
May 10, 2007·JAMA : the Journal of the American Medical Association·Bridget M Kuehn
Sep 22, 2007·The Clinical Journal of Pain·Nathaniel P KatzRoger Weiss

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Citations

Oct 18, 2012·Journal of Medical Toxicology : Official Journal of the American College of Medical Toxicology·Tammi Schaeffer
Aug 25, 2010·Drugs·Robert B Raffa, Joseph V Pergolizzi
Oct 26, 2012·Postgraduate Medicine·Marco Pappagallo, Marta Sokolowska
Nov 12, 2013·Expert Opinion on Drug Safety·Robert B RaffaJoseph V Pergolizzi
Dec 21, 2012·Expert Opinion on Drug Delivery·Laura M LourençoRobert N Jamison
Oct 12, 2013·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Edward MichnaMei Sheng
Jan 1, 2016·Clinical Pharmacokinetics·Carmen WalterJörn Lötsch
Jan 1, 2014·Pain Practice : the Official Journal of World Institute of Pain·Michael Zimmermann, Ute Richarz
Mar 27, 2013·Journal of Pain & Palliative Care Pharmacotherapy·Jeffrey A Gudin
Dec 8, 2014·The Journal of Pain : Official Journal of the American Pain Society·Andrew McKeownShannon M Smith
Jun 13, 2016·CNS Drugs·Nalini VadiveluJack M Berger
Aug 2, 2014·Therapeutic Advances in Drug Safety·Robert TaylorJoseph V Pergolizzi
Nov 8, 2018·Expert Review of Clinical Pharmacology·Andrea FanelliDaniela Ghisi
Nov 9, 2018·Expert Opinion on Drug Metabolism & Toxicology·Rand AhmadHamid Omidian
Sep 18, 2014·The Cochrane Database of Systematic Reviews·Bruno R da CostaPeter Jüni
Jul 22, 2018·BMJ Open·Emma L ParryGeorge Peat
Dec 22, 2010·The American Journal of Drug and Alcohol Abuse·Sandra A SpringerFrederick L Altice
Jul 15, 2016·Macromolecular Bioscience·Marjan HassanzadehShamseddin Ahmadi
Apr 14, 2018·Clinical Drug Investigation·Aaron J SalwanSam Harirforoosh
Apr 28, 2011·Current Opinion in Supportive and Palliative Care

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