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

Journal of Pain

Volumn 11, Issue 4, 2010, Pages 303-311

  Katz, Nathaniel ^a,b   Sun, Stephen ^c   Johnson, Franklin ^c   Stauffer, Joseph ^c,d  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Analgesic Research   (United States)

^c Alpharma Pharmaceuticals LLC   (United States)

^d JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

ALO 01; chronic pain; morphine; naltrexone; osteoarthritis; tampering

Indexed keywords

MORPHINE SULFATE; NALTREXONE; PARACETAMOL;

ADULT; AGED; ANALGESIA; ARTICLE; ASTHENIA; CHRONIC PAIN; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; CRYING; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEADACHE; HIP OSTEOARTHRITIS; HUMAN; KNEE OSTEOARTHRITIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCLE SPASM; PAIN ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SIDE EFFECT; SOMNOLENCE; STEADY STATE; TREATMENT DURATION; TREATMENT INDICATION; VOMITING; XEROSTOMIA;

ADULT; AGED; AGED, 80 AND OVER; ANALGESICS, OPIOID; CHRONIC DISEASE; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; MORPHINE; MORPHINE DEPENDENCE; NALTREXONE; NARCOTIC ANTAGONISTS; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE; PAIN MEASUREMENT; STREET DRUGS; TREATMENT OUTCOME;

EID: 77949917186     PISSN: 15265900     EISSN: 15288447     Source Type: Journal    
DOI: 10.1016/j.jpain.2009.07.017     Document Type: Article

References (29)

1. Altman R., Alarcon G., Appelrouth D., Bloch D., Borenstein D., Brandt K., Brown C., Cooke T.D., Daniel W., Feldman D., Greenwald R., Hochberg M., Howell D., Ike R., Kapila P., Kaplan D., Koopman W., Marino C., McDonald E., McShane D.J., Medsger T., Michel B., Murphy W.A., Osial T., Ramsey-Goldman R., Rothschild B., and Wolfe F. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum 34 (1991) 505-514
2. Altman R., Asch E., Bloch D., Bole G., Borenstein D., Brandt K., Christy W., Cooke T.D., Greenwald R., Hochberg M., Howell D., Kaplan D., Koopman W., Longley III S., Mankin H., McShane D.J., Medsger Jr. T., Meenan R., Mikkelsen W., Moskowitz R., Murphy W., Rothschild B., Segal M., Sokoloff L., and Wolfe F. Development of criteria for the classification and reporting of osteoarthritis: Classification of osteoarthritis of the knee: Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum 29 (1986) 1039-1049
3. Bashaw E.D., Kaiko R.F., Grandy R.P., Reder R.F., and Goldenheim P.D. Relative bioavailability of controlled-release morphine sulfate during naltrexone blockade. Int J Clin Pharmacol Ther 33 (1995) 524-529
4. Bellamy N., Buchanan W.W., Goldsmith C.H., Campbell J., and Stitt L.W. Validation study of WOMAC: A health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 15 (1988) 1833-1840
5. Cleeland C.S., and Ryan K.M. Pain assessment: Global use of the Brief Pain Inventory. Ann Acad Med Singapore 23 (1994) 129-138
6. Cone E.J. Ephemeral profiles of prescription drug and formulation tampering: Evolving pseudoscience on the Internet. Drug Alcohol Depend 83 Suppl 1 (2006) S31-S39
7. Crabtree B.L. Review of naltrexone, a long-acting opiate antagonist. Clin Pharm 3 (1984) 273-280
8. Gourlay G.K. Sustained relief of chronic pain: Pharmacokinetics of sustained release morphine. Clin Pharmacokinet [abstract 235] (1998) 173-190
9. Johnson FK, Ciric S, Boudriau S, Swearingen D, Stauffer J: Effect of food and sprinkling of pellets on applesauce on the pharmacokinetics of ALO-01 [abstract 99]. Presented at: 2008 American Association of Pharmaceutical Scientists Annual Meeting and Exposition; Atlanta, GA
10. Jones J., Johnson F., Wagner G., Stauffer J., and Sellers E. Evaluation of abuse potential of ALO-01, and extended release morphine sulfate plus sequestered naltrexone formulation, among recreational opioid users. J Pain [abstract 235] 9 4 Suppl 2 (2008) 34
11. KADIAN Capsules [Package Insert]. Morristown, NJ, Actavis US; 2008
12. Kaiko R.F., Grandy R.P., Reder R.F., Goldenheim P.D., and Sackler R.S. A bioequivalence study of oral controlled-release morphine using naltrexone blockade. J Clin Pharmacol 35 (1995) 499-504
13. Katz N., Sun S., Fox L., Johnson F., Wagner G., and Stauffer J. Efficacy and safety evaluation of an extended-release morphine sulfate formulation with sequestered naltrexone for the treatment of osteoarthritis. J Pain 9 Suppl 2 (2008) 41
14. Katz N.P., Adams E.H., Benneyan J.C., Birnbaum H.G., Budman S.H., Buzzeo R.W., Carr D.B., Cicero T.J., Gourlay D., Inciardi J.A., Joranson D.E., Kesslick J., and Lande S.D. Foundations of opioid risk management. Clin J Pain 23 (2007) 103-118
15. Katz N.P., Adams E.H., Chilcoat H., Colucci R.D., Comer S.D., Goliber P., Grudzinskas C., Jasinski D., Lande S.D., Passik S.D., Schnoll S.H., Sellers E., Travers D., and Weiss R. Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain 23 (2007) 648-660
16. Kuehn B.M. Scientists probe ways to curb opioid abuse without hindering pain treatment. JAMA 297 (2007) 1965-1967
17. Lipman AG, Jackson KC II: Opioid pharmacotherapy, in Warfield CA, Bajwa ZH (eds): Principles and Practices of Pain Medicine. New York, NY, 2004, pp 583-600
18. McCarberg B.H., and Barkin R.L. Long-acting opioids for chronic pain: Pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia. Am J Ther 8 (2001) 181-186
19. National Institute for Health and Clinical Excellence: Naltrexone for the Management of Opioid Dependence. London, UK, National Institute for Health and Clinical Excellence, 2007, pp 1-28
20. Resnick R.B., Volvavka J., Freedman A.M., and Thomas M. Studies of EN-1639A (naltrexone): A new narcotic antagonist. Am J Psychiatry 131 (1974) 646-650
21. ReVia naltrexone hydrochloride, product monograph. Pomona, NY, Duramed Pharmaceuticals, Inc, 2003
22. ReVia [package insert] (2007), Barr Pharmaceuticals, Inc, Montvale, NJ
23. Sloan P., and Babul N. Extended-release opioids for the management of chronic non-malignant pain. Expert Opin Drug Deliv 3 (2006) 489-497
24. Substance Abuse and Mental Health Services Administration. Results from the 2007 National Survey on Drug Use and Health: National Findings (2008), Office of Applied Studies, NSDUH Series H-34, DHHS Publication No. SMA 08-4343, Rockville, MD
25. US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER): Guidance for Industry: Statistical Approaches to Establishing Bioequivalence. 2001
26. US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER): Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations; Revision 1. 2003
27. Verebey K. The clinical pharmacology of naltrexone: Pharmacology and pharmacodynamics. In: Willette R.E., and Barnett G. (Eds). Naltrexone Pharmacochemistry and Sustained Release Preparations: Research Monograph (1981), Rockville, MD, National Institute on Drug Abuse 147-158
28. Woolf C.J., and Hashmi M. Use and abuse of opioid analgesics: Potential methods to prevent and deter non-medical consumption of prescription opioids. Curr Opin Invest Drugs 5 (2004) 61-66
29. Wright C., Kramer E.D., Zalman M.A., Smith M.Y., and Haddox J.D. Risk identification, risk assessment, and risk management of abusable drug formulations. Drug Alcohol Depend 83 Suppl 1 (2006) S68-S76