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Volumn 40, Issue 5, 2010, Pages 734-746

Long-term safety and efficacy of morphine sulfate and naltrexone hydrochloride extended release capsules, a novel formulation containing morphine and sequestered naltrexone, in patients with chronic, moderate to severe pain

Author keywords

Chronic pain; Morphine; Naltrexone; Opioid

Indexed keywords

EMBEDA; MORPHINE SULFATE; MORPHINE SULFATE PLUS NALTREXONE; NALTREXONE; UNCLASSIFIED DRUG;

EID: 78349272369     PISSN: 08853924     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpainsymman.2010.05.004     Document Type: Article
Times cited : (32)

References (44)
  • 2
    • 34547852667 scopus 로고    scopus 로고
    • Extended-release opioids for the management of chronic non-malignant pain
    • P. Sloan, and N. Babul Extended-release opioids for the management of chronic non-malignant pain Expert Opin Drug Deliv 3 2006 489 497
    • (2006) Expert Opin Drug Deliv , vol.3 , pp. 489-497
    • Sloan, P.1    Babul, N.2
  • 3
    • 0141920503 scopus 로고    scopus 로고
    • Burden of major musculoskeletal conditions
    • A.D. Woolf, and B. Pfleger Burden of major musculoskeletal conditions Bull World Health Organ 81 2003 646 656
    • (2003) Bull World Health Organ , vol.81 , pp. 646-656
    • Woolf, A.D.1    Pfleger, B.2
  • 4
    • 51649117401 scopus 로고    scopus 로고
    • The impact of pain on quality of life and the unmet needs of pain management: Results from pain sufferers and physicians participating in an Internet survey
    • B.H. McCarberg, B.D. Nicholson, K.H. Todd, T. Palmer, and L. Penles The impact of pain on quality of life and the unmet needs of pain management: results from pain sufferers and physicians participating in an Internet survey Am J Ther 15 2008 312 320
    • (2008) Am J Ther , vol.15 , pp. 312-320
    • McCarberg, B.H.1    Nicholson, B.D.2    Todd, K.H.3    Palmer, T.4    Penles, L.5
  • 6
    • 58949087497 scopus 로고    scopus 로고
    • Opioid treatment guidelines. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain
    • R. Chou, G.J. Fanciullo, and P.G. Fine Opioid treatment guidelines. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain J Pain 10 2009 113 130
    • (2009) J Pain , vol.10 , pp. 113-130
    • Chou, R.1    Fanciullo, G.J.2    Fine, P.G.3
  • 7
    • 10744224265 scopus 로고    scopus 로고
    • EULAR Recommendations 2003: An evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT)
    • K.M. Jordan, N.K. Arden, and M. Doherty EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT) Ann Rheum Dis 62 2003 1145 1155
    • (2003) Ann Rheum Dis , vol.62 , pp. 1145-1155
    • Jordan, K.M.1    Arden, N.K.2    Doherty, M.3
  • 8
    • 0036087972 scopus 로고    scopus 로고
    • The management of persistent pain in older persons
    • AGS Panel on Persistent Pain in Older Persons
    • AGS Panel on Persistent Pain in Older Persons The management of persistent pain in older persons J Am Geriatr Soc 50 6 Suppl 2002 S205 S224
    • (2002) J Am Geriatr Soc , vol.50 , Issue.6 SUPPL.
  • 9
    • 0033710649 scopus 로고    scopus 로고
    • Recommendations for the medical management of osteoarthritis of the hip and knee
    • American College of Rheumatology Subcommittee on Osteoarthritis Guidelines
    • American College of Rheumatology Subcommittee on Osteoarthritis Guidelines Recommendations for the medical management of osteoarthritis of the hip and knee Arthritis Rheum 43 2000 1905 1915
    • (2000) Arthritis Rheum , vol.43 , pp. 1905-1915
  • 10
    • 43649102347 scopus 로고    scopus 로고
    • Opioids in the management of chronic non-cancer pain: An update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines
    • A.M. Trescot, S. Helm, and H. Hansen Opioids in the management of chronic non-cancer pain: an update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines Pain Physician 11 2008 S5 S62
    • (2008) Pain Physician , vol.11
    • Trescot, A.M.1    Helm, S.2    Hansen, H.3
  • 11
    • 0242658912 scopus 로고    scopus 로고
    • Opioid therapy for chronic pain
    • J.C. Ballantyne, and J. Mao Opioid therapy for chronic pain N Engl J Med 349 2003 1943 1953
    • (2003) N Engl J Med , vol.349 , pp. 1943-1953
    • Ballantyne, J.C.1    Mao, J.2
  • 12
    • 0035350681 scopus 로고    scopus 로고
    • Long-acting opioids for chronic pain: Pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia
    • B.H. McCarberg, and R.L. Barkin Long-acting opioids for chronic pain: pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia Am J Ther 8 2001 181 186
    • (2001) Am J Ther , vol.8 , pp. 181-186
    • McCarberg, B.H.1    Barkin, R.L.2
  • 13
    • 0037252038 scopus 로고    scopus 로고
    • Responsible prescribing of opioids for the management of chronic pain
    • B. Nicholson Responsible prescribing of opioids for the management of chronic pain Drugs 63 2003 17 32
    • (2003) Drugs , vol.63 , pp. 17-32
    • Nicholson, B.1
  • 14
    • 45949106973 scopus 로고    scopus 로고
    • Chronic pain of osteoarthritis: Considerations for selecting an extended-release opioid analgesic
    • A. Gibofsky, and R.L. Barkin Chronic pain of osteoarthritis: considerations for selecting an extended-release opioid analgesic Am J Ther 15 2008 241 245
    • (2008) Am J Ther , vol.15 , pp. 241-245
    • Gibofsky, A.1    Barkin, R.L.2
  • 15
    • 27344432039 scopus 로고    scopus 로고
    • Treatment of persistent pain associated with osteoarthritis with controlled-release oxycodone tablets in a randomized controlled clinical trial
    • J.A. Markenson, J. Croft, P.G. Zhang, and P. Richards Treatment of persistent pain associated with osteoarthritis with controlled-release oxycodone tablets in a randomized controlled clinical trial Clin J Pain 21 2005 524 535
    • (2005) Clin J Pain , vol.21 , pp. 524-535
    • Markenson, J.A.1    Croft, J.2    Zhang, P.G.3    Richards, P.4
  • 16
    • 34250863296 scopus 로고    scopus 로고
    • National drug control policy and prescription drug abuse: Facts and fallacies
    • L. Manchikanti National drug control policy and prescription drug abuse: facts and fallacies Pain Physician 10 2007 399 424
    • (2007) Pain Physician , vol.10 , pp. 399-424
    • Manchikanti, L.1
  • 17
    • 34648831469 scopus 로고    scopus 로고
    • Opioid use and abuse: Is there a problem?
    • A.M. Gagnon, M. Kahan, and A. Srivastava Opioid use and abuse: is there a problem? Clin J Pain 23 2007 661 662
    • (2007) Clin J Pain , vol.23 , pp. 661-662
    • Gagnon, A.M.1    Kahan, M.2    Srivastava, A.3
  • 18
    • 33846423929 scopus 로고    scopus 로고
    • Opioid prescriptions soar: Increase in legitimate use as well as abuse
    • B.M. Kuehn Opioid prescriptions soar: increase in legitimate use as well as abuse JAMA 297 2007 249 251
    • (2007) JAMA , vol.297 , pp. 249-251
    • Kuehn, B.M.1
  • 19
    • 33846422411 scopus 로고    scopus 로고
    • Foundations of opioid risk management
    • N.P. Katz, E.H. Adams, and J.C. Benneyan Foundations of opioid risk management Clin J Pain 23 2007 103 118
    • (2007) Clin J Pain , vol.23 , pp. 103-118
    • Katz, N.P.1    Adams, E.H.2    Benneyan, J.C.3
  • 20
    • 77954644065 scopus 로고    scopus 로고
    • Relative oral bioavailability of morphine and naltrexone derived from crushed morphine sulfate and naltrexone hydrochloride extended-release capsules versus intact product and versus naltrexone solution: A single-dose, randomized-sequence, open-label, three-way crossover trial in healthy volunteers
    • F.K. Johnson, J.G. Stark, F.A. Bieberdorf, and J. Stauffer Relative oral bioavailability of morphine and naltrexone derived from crushed morphine sulfate and naltrexone hydrochloride extended-release capsules versus intact product and versus naltrexone solution: a single-dose, randomized-sequence, open-label, three-way crossover trial in healthy volunteers Clin Ther 32 2010 1149 1164
    • (2010) Clin Ther , vol.32 , pp. 1149-1164
    • Johnson, F.K.1    Stark, J.G.2    Bieberdorf, F.A.3    Stauffer, J.4
  • 21
    • 70449426117 scopus 로고    scopus 로고
    • Subjective effects and safety of whole and tampered morphine sulfate and naltrexone hydrochloride (ALO-01) extended-release capsules versus morphine solution and placebo in experienced non-dependent opioid users: A randomized, double-blind, placebo-controlled, crossover study
    • J. Stauffer, B. Setnik, and M. Sokolowska Subjective effects and safety of whole and tampered morphine sulfate and naltrexone hydrochloride (ALO-01) extended-release capsules versus morphine solution and placebo in experienced non-dependent opioid users: a randomized, double-blind, placebo-controlled, crossover study Clin Drug Invest 29 2009 777 790
    • (2009) Clin Drug Invest , vol.29 , pp. 777-790
    • Stauffer, J.1    Setnik, B.2    Sokolowska, M.3
  • 22
    • 77949917186 scopus 로고    scopus 로고
    • 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
    • N.P. Katz, S. Sun, F.K. Johnson, and J. Stauffer 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 J Pain 11 2010 303 311
    • (2010) J Pain , vol.11 , pp. 303-311
    • Katz, N.P.1    Sun, S.2    Johnson, F.K.3    Stauffer, J.4
  • 23
    • 70449419596 scopus 로고    scopus 로고
    • Efficacy and tolerability of ALO-01 (morphine sulfate extended-release with sequestered naltrexone hydrochloride) capsules in patients with chronic moderate-to-severe pain from osteoarthritis of the hip or knee [poster 238]
    • J.B. Jones, L. Fox, N. Katz, D. Morris, and J. Stauffer Efficacy and tolerability of ALO-01 (morphine sulfate extended-release with sequestered naltrexone hydrochloride) capsules in patients with chronic moderate-to-severe pain from osteoarthritis of the hip or knee [poster 238] Arch Phys Med Rehabil 89 2008 e97
    • (2008) Arch Phys Med Rehabil , vol.89 , pp. 97
    • Jones, J.B.1    Fox, L.2    Katz, N.3    Morris, D.4    Stauffer, J.5
  • 24
    • 38849171042 scopus 로고    scopus 로고
    • KADIAN (morphine sulfate extended-release) capsules for treatment of chronic, moderate-to-severe, nonmalignant pain
    • E.L. Ross, and K. Hahn KADIAN (morphine sulfate extended-release) capsules for treatment of chronic, moderate-to-severe, nonmalignant pain Int J Clin Pract 62 2008 471 479
    • (2008) Int J Clin Pract , vol.62 , pp. 471-479
    • Ross, E.L.1    Hahn, K.2
  • 25
    • 0041665111 scopus 로고    scopus 로고
    • The Clinical Opiate Withdrawal Scale (COWS)
    • D.R. Wesson, and W. Ling The Clinical Opiate Withdrawal Scale (COWS) J Psychoactive Drugs 35 2003 253 259
    • (2003) J Psychoactive Drugs , vol.35 , pp. 253-259
    • Wesson, D.R.1    Ling, W.2
  • 26
    • 0028395482 scopus 로고
    • Pain assessment: Global use of the Brief Pain Inventory
    • C.S. Cleeland, and K.M. Ryan Pain assessment: global use of the Brief Pain Inventory Ann Acad Med Singapore 23 1994 129 138
    • (1994) Ann Acad Med Singapore , vol.23 , pp. 129-138
    • Cleeland, C.S.1    Ryan, K.M.2
  • 28
    • 78349242754 scopus 로고    scopus 로고
    • Barr Pharmaceuticals, Inc. Montvale, NJ
    • ® 2007 Barr Pharmaceuticals, Inc. Montvale, NJ [package insert]
    • (2007) ®
  • 29
    • 0019729111 scopus 로고
    • The clinical pharmacology of naltrexone: Pharmacology and pharmacodynamics
    • K. Verebey The clinical pharmacology of naltrexone: pharmacology and pharmacodynamics R.E. Willette, G. Barnett, Narcotic antagonists: Naltrexone pharmacochemistry and sustained release preparations 1980 US Department of Health and Human Services Rockville, MD 147 158 NIDA Research Monograph 28. DHHS publication (ADM) 81-92
    • (1980) Narcotic Antagonists: Naltrexone Pharmacochemistry and Sustained Release Preparations , pp. 147-158
    • Verebey, K.1
  • 30
    • 36448934161 scopus 로고    scopus 로고
    • Quantitative analysis of naltrexone and 6beta-naltrexol in human, rat, and rabbit plasma by liquid chromatograpy-electrospray ionization tandem mass spectrometry with application to the pharmacokinetics of Depotrex in rabbits
    • M.H. Slawson, M. Chen, and S.D. Comer Quantitative analysis of naltrexone and 6beta-naltrexol in human, rat, and rabbit plasma by liquid chromatograpy-electrospray ionization tandem mass spectrometry with application to the pharmacokinetics of Depotrex in rabbits J Anal Toxicol 31 2007 453 461
    • (2007) J Anal Toxicol , vol.31 , pp. 453-461
    • Slawson, M.H.1    Chen, M.2    Comer, S.D.3
  • 31
    • 0030749602 scopus 로고    scopus 로고
    • Determination of naltrexone and 6-beta-naltrexol in plasma by solid-phase extraction and gas chromatography-negative ion chemical ionization-mass spectrometry
    • W.M.D.E. Huang, R.L. Foltz, and S.L. Walsh Determination of naltrexone and 6-beta-naltrexol in plasma by solid-phase extraction and gas chromatography-negative ion chemical ionization-mass spectrometry J Anal Toxicol 21 1997 252 257
    • (1997) J Anal Toxicol , vol.21 , pp. 252-257
    • Huang, W.M.D.E.1    Foltz, R.L.2    Walsh, S.L.3
  • 32
    • 0021219060 scopus 로고
    • Bioequivalence, dose-proportionality, and pharmacokinetics of naltrexone after oral administration
    • M.C. Meyer, A.B. Straughn, M.W. Lo, W.L. Schary, and C.C. Whitney Bioequivalence, dose-proportionality, and pharmacokinetics of naltrexone after oral administration J Clin Psychiatry 45 9 Pt 2 1984 15 19
    • (1984) J Clin Psychiatry , vol.45 , Issue.9 PART 2 , pp. 15-19
    • Meyer, M.C.1    Straughn, A.B.2    Lo, M.W.3    Schary, W.L.4    Whitney, C.C.5
  • 33
    • 0019729105 scopus 로고
    • Current status of preclinical research on disposition, pharmacokinetics, and metabolism of naltrexone
    • A.L. Misra Current status of preclinical research on disposition, pharmacokinetics, and metabolism of naltrexone R.E. Willette, G. Barnett, Narcotic antagonists: Naltrexone pharmacochemistry and sustained-release preparations 1981 US Department of Health and Human Services Rockville, MD 132 146 NIDA Research Monograph 28. DHHS publication (ADM) 81-92
    • (1981) Narcotic Antagonists: Naltrexone Pharmacochemistry and Sustained-release Preparations , pp. 132-146
    • Misra, A.L.1
  • 34
    • 78349274801 scopus 로고    scopus 로고
    • In vivo human opiate receptor occupancy of naltrexone: A dose-response analysis
    • AccessedSeptember10,2010
    • Wong DF, Ye W, Zhou Y, et al. In vivo human opiate receptor occupancy of naltrexone: a dose-response analysis. Abstract presented from: The Society for Neuroscience conference. 2006. Available from http://cms.sfn.org/index.aspx? pagename=abstracts-ampublications. Accessed September 10, 2010.
    • (2006) Abstract Presented From: The Society for Neuroscience Conference
    • Wong, D.F.1    Ye, W.2    Zhou, Y.3
  • 35
    • 34247499785 scopus 로고    scopus 로고
    • Long-term use of controlled-release oxycodone for noncancer pain: Results of a 3-year registry study
    • R.K. Portenoy, J.T. Farrar, and M.M. Backonja Long-term use of controlled-release oxycodone for noncancer pain: results of a 3-year registry study Clin J Pain 23 2007 287 299
    • (2007) Clin J Pain , vol.23 , pp. 287-299
    • Portenoy, R.K.1    Farrar, J.T.2    Backonja, M.M.3
  • 36
    • 34250888139 scopus 로고    scopus 로고
    • Opioid analgesia: Perspectives on right use and utility
    • J.C. Ballantyne Opioid analgesia: perspectives on right use and utility Pain Physician 10 2007 479 491
    • (2007) Pain Physician , vol.10 , pp. 479-491
    • Ballantyne, J.C.1
  • 37
    • 23244440994 scopus 로고    scopus 로고
    • Transdermal fentanyl versus sustained release oral morphine in strong-opioid naive patients with chronic low back pain
    • L.G. Allan, U. Rucharz, K. Simpson, and R. Slappendel Transdermal fentanyl versus sustained release oral morphine in strong-opioid naive patients with chronic low back pain Spine 30 2005 2484 2490
    • (2005) Spine , vol.30 , pp. 2484-2490
    • Allan, L.G.1    Rucharz, U.2    Simpson, K.3    Slappendel, R.4
  • 38
    • 0032190657 scopus 로고    scopus 로고
    • Prolonged treatment with transdermal fentanyl in neuropathic pain
    • P.L. Dellemijn, H. van Duijn, and J.A. Vanneste Prolonged treatment with transdermal fentanyl in neuropathic pain J Pain Symptom Manage 16 1998 220 229
    • (1998) J Pain Symptom Manage , vol.16 , pp. 220-229
    • Dellemijn, P.L.1    Van Duijn, H.2    Vanneste, J.A.3
  • 39
    • 17944378873 scopus 로고    scopus 로고
    • Evaluation of long-term efficacy and safety of transdermal fentanyl in the treatment of chronic non-cancer pain
    • K. Milligan, M. Lanteri-Minet, and K. Borchert Evaluation of long-term efficacy and safety of transdermal fentanyl in the treatment of chronic non-cancer pain J Pain 2 2001 197 204
    • (2001) J Pain , vol.2 , pp. 197-204
    • Milligan, K.1    Lanteri-Minet, M.2    Borchert, K.3
  • 40
    • 33748036026 scopus 로고    scopus 로고
    • Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain
    • B. Nicholson, E. Ross, J. Sasaki, and A. Weil Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain Curr Med Res Opin 22 2006 1503 1514
    • (2006) Curr Med Res Opin , vol.22 , pp. 1503-1514
    • Nicholson, B.1    Ross, E.2    Sasaki, J.3    Weil, A.4
  • 41
    • 0342577768 scopus 로고    scopus 로고
    • Around-the-clock, controlled-release oxycodone therapy for osteoarthritis-related pain: Placebo-controlled trial and long-term evaluation
    • S.H. Roth, R.M. Fleischmann, and F.X. Burch Around-the-clock, controlled-release oxycodone therapy for osteoarthritis-related pain: placebo-controlled trial and long-term evaluation Arch Intern Med 160 2000 853 860
    • (2000) Arch Intern Med , vol.160 , pp. 853-860
    • Roth, S.H.1    Fleischmann, R.M.2    Burch, F.X.3
  • 42
    • 65749098996 scopus 로고    scopus 로고
    • Long-term safety, tolerability, and efficacy of OROS hydromorphone in patients with chronic pain
    • M. Wallace, D.E. Moulin, and R.L. Rauck Long-term safety, tolerability, and efficacy of OROS hydromorphone in patients with chronic pain J Opioid Manage 5 2009 97 105
    • (2009) J Opioid Manage , vol.5 , pp. 97-105
    • Wallace, M.1    Moulin, D.E.2    Rauck, R.L.3
  • 43
    • 0036239777 scopus 로고    scopus 로고
    • Efficacy and safety of once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: Results from a randomized, placebo-controlled, double-blind trial and an open-label trial
    • J.R. Caldwell, R.J. Rapoport, and J.C. Davis Efficacy and safety of once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label trial J Pain Symptom Manage 23 2002 278 291
    • (2002) J Pain Symptom Manage , vol.23 , pp. 278-291
    • Caldwell, J.R.1    Rapoport, R.J.2    Davis, J.C.3
  • 44
    • 38349175953 scopus 로고    scopus 로고
    • Long-term opioid therapy for chronic noncancer pain: A systematic review and meta-analysis of efficacy and safety
    • M. Noble, S.J. Tregear, J.R. Treadwell, and K. Schoelles Long-term opioid therapy for chronic noncancer pain: a systematic review and meta-analysis of efficacy and safety J Pain Symptom Manage 35 2008 214 228
    • (2008) J Pain Symptom Manage , vol.35 , pp. 214-228
    • Noble, M.1    Tregear, S.J.2    Treadwell, J.R.3    Schoelles, K.4


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