ADMINISTRATION OF AGONIST-ANTAGONIST IN OPIOID-DEPENDENT PATIENTS

• US 20090060871A1
• Filed: 10/24/2008
• Published: 03/05/2009
• Est. Priority Date: 04/25/2006
• Status: Abandoned Application

• Current Assignee: Daria Alexandrovna Ocheret, Efim David Nezhinsky, Levon Gevorkovich Isakulyan, Michael Victor Voronkov
• Original Assignee: Daria Alexandrovna Ocheret, Efim David Nezhinsky, Levon Gevorkovich Isakulyan, Michael Victor Voronkov
• Inventors: OCHERET, Daria Alexandrovna, NEZHINSKY, Efim David, ISAKULYAN, Levon Gevorkovich, VORONKOV, Michael Victor
• Application Number:
  US12/257,457
• Publication Number:
  US 20090060871A1
• Time in Patent Office: Days
• US Class Current: 424/85.400
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61P 25/36 Opioid-abuse
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/18 for HIV

Abstract

A method for reducing psychological opioid dependence includes selecting a patient addicted to an opioid and administering to the patient an opioid agonist-antagonist for at least 14 days, thereby reducing craving for the opioid in the patient. An opioid agonist-antagonist is administered in a patient needing an average adherence to a treatment protocol of at least 95 percent. A non-injectable formulation containing an agonist-antagonist also is disclosed.

Claims

1. A method for stabilizing inconsistencies associated with opioid dependence, the method comprising:

a. selecting a patient addicted to an opioid; and

b. administering to the patient an opioid agonist-antagonist for at least 14 days, thereby stabilizing said inconsistencies.

2. The method of claim 1, wherein the opioid is selected from the group consisting of heroin, codeine, codeine phosphate, tramadol, home-made opiate and any combination thereof.

3. The method of claim 1, wherein the opioid agonist-antagonist is selected from the group consisting of nalbuphine, butorphanol, pentazocine and any combination thereof.

4. The method of claim 1, wherein the opioid agonist-antagonist is nalbuphine.

5. The method of claim 1, wherein the patient also suffers from an infection selected from the group consisting of HIV, tuberculosis, herpes, hepatitis B, hepatitis C and any combination thereof.

6. The method of claim 5, wherein the patient also receives ARV treatment.

7. The method of claim 1, wherein the agonist-antagonist is administered by injection.

8. The method of claim 1, wherein the agonist-antagonist is administered orally.

9. The method of claim 1, wherein the agonist-antagonist is administered once or twice daily.

10. The method of claim 1, wherein the agonist-antagonist is a synthetic, semi-synthetic or naturally occurring compound.

11. The method of claim 1, wherein the patient also has an alcohol dependency.

12. The method of claim 1, wherein said inconsistencies are behavioral, psychological or both.

13. The method of claim 1, wherein the opioid agonist-antagonist is administered in combination with one or more agonist(s) and/or antagonist(s).

14. The method of claim 1, wherein the opioid agonist-antagonist is administered in combination with another treatment for opiate addiction.

15. A method for maintaining an opioid-dependent patient on a treatment regimen, the method comprising:

a. selecting an opioid-dependent patient in need of an average adherence to the treatment regimen of at least 95 percent; and

b. administering to the selected patient a combination of a treatment component and, for at least a month, an opioid receptor agonist-antagonist, whereby the patient'"'"'s average adherence to the treatment regimen, at he end of he at least a month, is no less than 95 percent.

16. The method of claim 15, wherein the treatment regimen is an ARV regimen.

17. The method of claim 16, wherein the ARV regimen includes abacavir, didanosine, emtricitabine, lamivudine, zidovudine, stavudine, stavudine, tenofovir, zalcitabine, delavirdine, efavirenz, nevirapine, amprenavir, atazanavir, fosamprenavir, indinavir, lopinavir, ritonavir, nelfinavir, saquinavir, enfuvirtide, acyclovir, interferons and any combination thereof.

18. The method of claim 15, wherein the patient'"'"'s average adherence, at he end of the at least a month is at least.

19. The method of claim 15, wherein the patient is HIV-positive.

20. The method of claim 15, wherein the opioid is selected from the group consisting of heroin, codeine, codeine phosphate, tramadol, home-made opiate and any combination thereof.

21. The method of claim 15, wherein the opioid agonist-antagonist is selected from the group consisting of nalbuphine, butorphanol, pentazocine and any combination thereof.

22. The method of claim 15, wherein the agonist-antagonist is a synthetic, semi-synthetic or naturally occurring compound.

23. The method of claim 15, wherein the patient also has an alcohol dependency.

24. The method of claim 15, wherein the treatment component and the opioid agonist-antagonist are administered on an individualized schedule.

25. The method of claim 15, wherein the treatment component and the opioid agonist-antagonist are administered on the same schedule.

26. The method of claim 15, wherein the opioid agonist-antagonist is administered in combination with one or more agonist(s) and/or antagonist(s).

27. The method of claim 15, wherein the opioid agonist-antagonist is administered in combination with another treatment for opiate addiction.

28. A method for maintaining an HIV-infected, opioid-dependent patient on an ARV regimen, the method comprising administering to the patient an ARV component in combination with an opioid receptor agonist-antagonist, wherein the opioid receptor agonist antagonist is administered for no less than a month and, at the end of the at least a month, the patient'"'"'s average adherence to the ARV regimen is at least 95 percent.

29. A method for treating an HIV-infected patient, the method comprising:

a. selecting an opioid-dependent patient having an average adherence to an ARV regimen that is less that 95 percent; and

b. administering to the patient ARV medication in combination with nalbuphine.

30. A method for maintaining an average compliance to an ARV regiment of at least 95 percent in an opioid-dependent patient, the method comprising administering to the patient ARV medication in combination with an opioid receptor agonist-antagonist.

31. A non-injectable formulation for managing opioid-addiction, the formulation comprising:

a. an active component including free-base nalbuphine or pharmaceutically acceptable derivative or salt of nalbuphine; and

b. a release modifying component,

wherein the formulation is in tablet or capsule form.

32. The formulation of claim 31, wherein the free-base nalbuphine or pharmaceutically acceptable derivative or salt of nalbuphine is present in the formulation in an amount of at least 5 milligrams.

33. The formulation of claim 31, wherein the release modifying component is a carbomer, hydroxypropylmethylcellulose or any combination thereof.

34. The formulation of claim 31, further comprising an additive component.

35. A kit comprising the formulation of claim 31.

36. A transdermal delivery device for managing opioid-addiction, wherein said device includes an opioid agonist-antagonist.

37. A non-injectable formulation for managing opioid-addiction, the formulation comprising an agonist-antagonist, wherein the formulation is in the form of a syrup, suppository, powder, inhalable aerosol, sublingual spray, intranasal spray or intranasal aerosol.

38. A method for severing an association with injectable opiates, in an opiate using patient, the method comprising administering to the opiate using patient a non-injectable formulation which includes an agonist-antagonist for at least 14 days.

39. Use of an agonist-antagonist for the manufacture of a medicament for stabilizing inconsistencies associated with opioid dependence.

40. Use of an agonist-antagonist for the manufacture of a medicament for maintaining an opioid-dependent patient on a treatment regimen.

41. The method of claim 40, wherein the patient is HIV-positive and the treatment regimen is an ARV regimen.