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(12) United States Patent (10) Patent No.: US 8,163,731 B2 Slater Et Al

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(12) United States Patent (10) Patent No.: US 8,163,731 B2 Slater Et Al USOO8163.731B2 (12) United States Patent (10) Patent No.: US 8,163,731 B2 Slater et al. (45) Date of Patent: Apr. 24, 2012 (54) METHOD AND DOSAGE REGIMENS FOR OTHER PUBLICATIONS ELMINATING ACHEMICAL SUBSTANCE IN Abramowitz, M.(Editor). Buprenorphine: An Alternative to Metha BLOOD done. The Medical Letter, (2003), 13-15, vol. 45, (Issue W1150A)Feb. 17. (75) Inventors: Kenneth C. Slater, Manchester, MA AZar, M.R. et al. A Non-invasive gating device for continuous drug (US); Brenda E. Richardson, delivery that allows control over the timing and duration of sponta neous opiate withdrawal. J.Neurosci. Methods,(May 30, 2004), 129 Manchester, MA (US); Scott M. 35, vol. 135 (1-2). Connors, Methuen, MA (US); Wei-wei Barnett, P.G. et al. Research Report. A Meta-Analysis Comparing Chang, Boston, MA (US) Buprenorphine to Methadone for Treatment of Opiate Dependence. Addiction(2001),683-690, vol. 96. (73) Assignee: Rhodes Technologies, Coventry, RI Barnett, P.G. et al. The Cost-effectiveness of buprenorphine mainte (US) nance therapy for opiate addiction in the United States. Addic tion(2001), 1267-1278,V96. (*) Notice: Subject to any disclaimer, the term of this (Continued) patent is extended or adjusted under 35 U.S.C. 154(b) by 477 days. Primary Examiner — Brandon Fetterolf Assistant Examiner — Kathrien Cruz (21) Appl. No.: 12/195,143 (74) Attorney, Agent, or Firm — Brinks Hofer Gilson & Lione (22) Filed: Aug. 20, 2008 (57) ABSTRACT (65) Prior Publication Data A method of reducing the concentration of a chemical or drug US 201O/OO48535A1 Feb. 25, 2010 Substance in the blood plasma that targets the same or similar receptors as the normal neurotransmitters in the central or (51) Int. Cl. peripheral nervous system includes titrating an initial peak A6 IK3I/485 (2006.01) concentration of the chemical or drug Substance in the blood A6 IK3I/554 (2006.01) for a predefined dosing period, titrating a lowest concentra A63/479 (2006.01) tion level of the chemical or drug substance in the blood (52) U.S. Cl. .................... 514/211.13: 514/282: 514/305 immediately before the end of the dosing period, and provid (58) Field of Classification Search ............. 514/211.13, ing a plurality of Subsequent dosing periods where each Sub 514/282,305 sequent dosing period requires administration of a dosing See application file for complete search history. amount of the chemical or drug Substance and titrating of the peak concentration and the lowest concentration level to (56) References Cited ensure that the lowest concentration level of the chemical or drug Substance in the blood plasma for the Subsequent dosing U.S. PATENT DOCUMENTS period is decreased by not more than five percent of the lowest 6,277.384 B1* 8/2001 Kaiko et al. .................. 424/400 concentration level of the previous dosing period and where 7,172,767 B2 2/2007 Kaiko et al. the plurality of dosing periods added together extends the method for seventy days or more. FOREIGN PATENT DOCUMENTS CA 2621575 A1 8/2008 12 Claims, 4 Drawing Sheets 16 14 V 12 d E O g 8 2. 6 ? 40 SO 60 70 80 Days in Treatment US 8,163,731 B2 Page 2 OTHER PUBLICATIONS Strain, E.C. etal. Buprenorphine Versus Methadone in the Treatment of Opioid Dependence: Self Reports, Urinanalysis, and Addiction Becker, A.B. et al. Gradual Dose Taper Following Chronic Severity Index. Journal of Clinical Psychopharmacology. (Feb. 1996) Buprenorphine. American Journal of Addictions. (2001), 111 58-67 vol. 16 No. 1. 121, vol. 10. Strang, Jand Gossop, M. Comparison of Linear versus Inverse Expo Bickel, W.K. et al. Buprenorphine dosing every 1.2 or 3 Days in opioid-dependent patients. Psychopharmacology (1999) 111-11, vol. nential Methadone Reduction Curves in the Detoxification of Opiate 146. Addicts. Addictive Behavior. (1990), 541-547, vol. 15. Breen, C.L. et al. Cessation of methadone maintenance treatment Camarasa, X. et al. Naltrexone-assisted rapid methadone discontinu using buprenorphine:transfer from methadone to buprenorphine and ation: A Pilot Study, European Addition Research, 2007, vol. 13, pp. Subsequent buprenorphine reductions. Drug and Alcohol Depen 20-24. dence (2003),49-55, vol. 71. Strain, E. C. etal. Relative bioavailability of different buprenorphine Calsyn, D.A. etal. Slow Tapering From Methadone Maintenance in a formulations under chronic dosing conditions, Drub and Alcohol Program Encouraging Indefinite Maintenance. Journal of Substance Dependence, 2004, vol. 74, pp. 37-43, Elsevier. Abuse Treatment (2006), 159-163, vol. 30. Gilson, A.M., et al., A Reassessment of Trends in the Medical use and Caplehorn, J. Comments on Matticket al:The Need for Independent Abuse of Opioid Analgesics and Implications for Diversion Control: Data Reanalyses. Addiction (2000) 1633-1634, vol. 98. 1997-2002, Journal of Pain and Symptom Management, 2004, vol. Chawarski, M.C. etal. Buprenorphine Tablet Versus Liquid: A Clini 28, No. 2. cal Trial comparing Plasma Levels, Efficacy, and Symptoms.Journal Miller, N. S. and Greenfield, A., Patient Characteristics and Risks of Substance Abuse Treatment.(2005),307-312. Factors for Development of Dependence on Hydrocodone and Fiellin, D.A & O'Connor, P.G. New Federal Initiatives to Enhance Oxycodone, American Journal of Therapeutics, 2004, vol. 11, pp. the Medical Treatment of Opioid Dependence. Annals of Internal 26-32. Medicine(2002),688-692, vol. 137. Application for Inclusion of Buprenorphine in the WHO Model List Fiellin, D.A. et al. Counseling Plus Buprenorphine-Naloxone of Essential Medicines, WHO: Department of Mental Health and Mainetenance Therapy for Opioid Dependence. The New England Substance Abuse, 2004, 1-49. Journal of Medicine(2006).365-374, vol. 355. ACT Methadone Treatment Guidelines, ACT Health, 2003, 1-102. Law, F.D. et al. The Clinical use of Buprenorphine in Opiate Bickel, Warren K. et al., “Buprenorphine Treatment of Opioid Addiction: Evidence and Practice. Acta Neuropsychiatrica, Dependence: A Review.” Experimental and Clinical (2004).246-274, vol. 16. Litten.R.Z. & Allen, J.P. Medications for Alcohol, Illicit Drug, and Psychopharmacology, 1995, pp. 477-489, 3(4), American Psycho Tobacco Dependence. An Update of Research Findings. Journal of logical Association, Inc., US. Substance Abuse Treatment (1999) 105-112 vol. 16.No. 2. Bickel, Warren K. et al., “Effects of Adding Behavioral Treatment to Mahowald, M.L. Opioid use by Patients in an Orthopedics Spine Opioid Detoxification with Buprenorphine.” Journal of Consulting Clinic. Arthritis and Rheumatism (2005).312-321, vol. 52. and Clinical Psychology, 1997, pp. 803-810, 65(5), American Psy Marsch, L.A. et al. Comparison of Pharmacological Treatments for chological Association, Inc., US. Opioid-Dependent Adolescents: A Randomized Controlled Trial. Johnson, Rolley E. et al., “Buprenorphine: how to use it right.” Drug Archives of General Psychiatry.(2005), 1157-116 vol. 62. and Alcohol Dependence, 2003, pp. S59-S77, 70, Elsevier Science Mattick, R.P. et al. Buprenorphine versus Methadone Maintenance Ireland, Ltd. Theralpy: A Randomized Double-Blind Trial With 405 Opioid Kuhlman, James J., Jr. et al., “Relationship of plasma buprenorphine Dependent Patients. Addiction(2003),441-452, vol. 98. and norbuprenorphine to withdrawal symptoms during dose induc O'Connor, P.G. Methods of Detoxification and Their Role in Treating tion, maintenance and withdrawal from Sublingual buprenorphine.” Patients with Opioid Dependence.JAMA (2005),961-963, vol. 294. Addiction, 1998, pp. 549-559, 93 (4), Society for the Study of Addic O'Connor, P.G. et al. Three Methods of Opioid Detoxification in a tion to Alcohol and Other Drugs, Carfax Publishing Limited. Primary Care Setting. Ann Inter.Med. (1997), 526-530 vol. 127. Wolff, Kim et al., “Methadone Concentrations in Plasma and Their Phillips, G.T. & Bradley, B. The Influence of Psychological Factors Relationship to Drug Dosage.” Clinical Chemistry, 1991, pp. 205 on the Opiate Withdrawal Syndrome. British Journal of Psychia 209, 37(2). try(1986), 235-238, vol. 149. European Search Report, European Application No. EP 09 168344. Raisch, D.W. et al. Opioid Dependence Treatment, Including Johnson, Rolley E. et al., Buprenorphine: how to use it right, Drug Buprenorphine/Naloxone. AnnPharmacother (2002) 312-321 vol. and Alcohol Dependence, 70 (2003), pp. S59-S77. 36. Becker, Ami B. et al., Gradual Dose Taper Following Chronic Raistrick, D.et al. A Comparison of Buprenorphine and Lofexidine Buprenorphine, the American Journal on Addiction, 10 (2001), pp. for Community Opiate Detoxification: Results From a Randomized 111-121. Controlled Trial. Addiction 92005) 1860-1862 vol. 100. Amass, Leslie et al., A Preliminary Investigation of Outcome Fol Rosenblatt A.B. & Nagy A.M. Management of Pain in Addicted lowing Gradual or Rapid Bupronerphine Detoxification, Journal of Illicit and Legal Substance Abusing Patients.Pain Practice.(2005), Addictive Diseases, vol. 13, No. 3, 1994, pp. 33-45. 2-10, vol. 5.No. 1. Bickel, Warren K. et al., Effects of Adding Behavioral Treatment to Schottenfeld, R.S. et al. Thrice Weekly Versus Daily Buprenorphine Opioid Detoxification With Buprenorphine, Journal of Consulting Maintenance. Biol. Psychiatry (2000), 1072-1079, vol. 47. and Clinical Psychology, American Psychological Association, vol. Simpson, D.D. etal. Drug Abuse Treatment Process Components that 65, No. 5, 1997, pp. 803-810. Improve Retention. Journal of Substance Abuse Treatment. (1997),565-572, vol. 14 No. 6. * cited by examiner U.S. Patent Apr. 24, 2012 Sheet 1 of 4 US 8,163,731 B2 sS3s& S. S S VO S N O OO t v y 6u u esop AleO U.S. Patent Apr. 24, 2012 Sheet 2 of 4 US 8,163,731 B2 d N w v w va CO O ra n O H Vo On o in C r- cy S. d. st oxo od N N N d d (eleos fo) fu u esop AlleO U.S. Patent Apr. 24, 2012 Sheet 3 of 4 US 8,163,731 B2 | (eleos 6o) (u/6u) uope JueouOO U.S.
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