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Claims for Patent: 6,559,158

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Claims for Patent: 6,559,158

Title: Use of methylnaltrexone and related compounds to treat chronic opioid use side affects
Abstract:A method of preventing or treating an opioid-induced side effect in a patient who has been chronically taking opioids, the method comprising administering a quaternary derivative of noroxymorphone in an amount sufficient to prevent or treat the side effect in the patient, but which amount would be insufficient to treat a patient with the same opioid-induced side effect who had not chronically been administered opioids.
Inventor(s): Foss; Joseph F. (Chicago, IL), Roizen; Michael F. (Chicago, IL), Moss; Jonathan (Chicago, IL), Yuan; Chun-Su (Chicago, IL), Drell; William (San Diego, CA)
Assignee: UR Labs, Inc. (Reno, NV) The University of Chicago (Chicago, IL)
Application Number:09/669,358
Patent Claims: 1. A method of preventing or treating an opioid-induced side effect in a chronic opioid patient, the method comprising administering a quaternary derivative of noroxymorphone in an amount sufficient to prevent or treat the side effect in the patient, wherein said amount is insufficient to treat the side effect in a patient to whom opioids have not been chronically administered and wherein said amount is such that peak plasma concentrations do not exceed 100 ng/ml.

2. The method of claim 1 wherein the quaternary derivative is methylnaltrexone.

3. The method of claim 2 wherein the side effect to be prevented or treated is constipation.

4. The method of claim 2 wherein the side effect is selected from the group consisting of dysphoria, pruritus, and urinary retention.

5. The method of claim 2 wherein the methylnaltrexone is enterically coated.

6. The method of claim 2 wherein the methylnaltrexone is administered in a form that is not enterically coated.

7. The method of claim 6 wherein the methylnaltrexone is administered orally.

8. The method of claim 2 wherein the methylnaltrexone is administered at a dosage of about 0.001 to about 5 mg/kg body weight.

9. The method of claim 2 wherein the methylnaltrexone is administered at a dose of less than about 3 mg/kg body weight.

10. The method of claim 2 wherein the methylnaltrexone is administered at a dose of less than about 1 mg/kg body weight.

11. The method of claim 2 wherein the methylnaltrexone is administered at a dose of less than about 0.1 mg/kg body weight.

12. The method of claim 2 wherein the peak plasma concentrations do not exceed 50 ng/ml.

13. The method of claim 2 wherein the peak plasma concentrations do not exceed 20 ng/ml.

14. The method of claim 2 wherein the peak plasma concentrations do not exceed 10 ng/ml.

15. The method of claim 2 wherein the methylnaltrexone is administered orally.

16. The method of claim 15 wherein the peak plasma concentrations do not exceed 50 ng/ml.

17. The method of claim 15 therein the peak plasma concentrations do not exceed 26 ng/ml.

18. The method of claim 15 wherein the peak plasma concentrations do not exceed 20 ng/ml.

19. The method of claim 15 wherein the peak plasma concentrations do not exceed 10 ng/ml.

20. The method of claim 2 wherein the methylnaltrexone is administered orally in a form that is enterically coated.

21. The method of claim 1 wherein the side effect to be prevented or treated is constipation.

22. The method of claim 1 wherein the side effect is selected from the group consisting of dysphoria, pruritus, and urinary retention.

23. The method of claim 1, wherein the opioid and the quaternary derivative of noroxymorphone are combined in an oral dose.

24. The method of claim 23 wherein the quaternary derivative is enterically coated.

25. The method of claim 1 wherein the quaternary derivative is administered orally in a form that is not enterically coated.

26. The method of claim 1 wherein the quaternary derivative is administered orally.

27. The method of claim 26 wherein the quaternary derivative is administered orally in a form that is enterically coated.

28. The method of claim 1 wherein the peak plasma concentrations do not exceed 50 ng/ml.

29. The method of claim 1 wherein the peak plasma concentrations do not exceed 20 ng/ml.

30. The method of claim 1 wherein the peak plasma concentrations do not exceed 10 ng/ml.

31. A method of preventing or treating opioid-induced constipation, the method comprising: determining how long the patient has been administered opioids; selecting a dose of a quaternary derivative of noroxymorphone based on the length of time the patient has been administered opioids, wherein the dose selected for a chronic opioid patient is at least 10% lower than the dose selected for a patient not chronically administered opioids, and wherein the dose is administered in an amount such that peak plasma concentrations do not exceed 100 ng/ml; and administering the selected dose of the quaternary derivative of noroxymorphone to the patient.

32. The method of claim 31 wherein the dose selected for a patient chronically administered opioids is at least 20% lower than the dose selected for a patient not chronically administered opioids.

33. The method of claim 31 wherein the dose selected for a patient chronically administered opioids is at least 30% lower than the dose selected for a patient not chronically administered opioids.

34. The method of claim 31 wherein the dose selected for a patient chronically administered opioids is at least 50% lower than the dose selected for a patient not chronically administered opioids.

35. The method of claim 31 wherein the dose selected for a patient chronically administered opioids is at least 70% lower than the dose selected for a patient not chronically administered opioids.

36. A method of preventing or reducing constipation in a chronic opioid patient, the method comprising administering a quaternary derivative of noroxymorphone in an amount sufficient to prevent or reduce the constipation in the patient, wherein said amount is not sufficient to reduce the constipation in a patient to whom opioids have not been chronically administered, and wherein said amount is administered in an amount such that peak plasma concentrations do not exceed 100 ng/ml.

37. A method of preventing or reducing urinary retention in a chronic opioid patient, the method comprising administering a quaternary derivative of noroxymorphone in an amount sufficient to prevent or reduce the urinary retention in the patient, where said amount is not sufficient to reduce the urinary retention in a patient to whom opioids have not been chronically administered, and wherein said amount is administered in an amount such that peak plasma concentrations do not exceed 100 ng/ml.

38. A method of preventing or reducing dysphoria in a chronic opioid patient, the method comprising administering a quaternary derivative or noroxymorphane in an amount sufficient to prevent or reduce the dysphoria in the patient, wherein said amount is not sufficient to reduce the dysphoria in a patient to whom opiods have not been chronically administered, and wherein said amount is administered in an amount such that peak plasma concentrations do not exceed 100 ng/ml.

39. A method of preventing or reducing pruritus in a chronic opioid patient, the method comprising administering a quaternary derivative or noroxymorphane in an amount sufficient to prevent or reduce the dysphoria in the patient, wherein said amount is not sufficient to reduce the pruritus in a patient to whom opiods have not been chronically administered, and wherein said amount is administered in an amount such that peak plasma concentrations do not exceed 100 ng/ml.

40. The method of any of claims 31, 36, 37, 38, or 39 wherein the peak plasma concentrations do not exceed 50 ng/ml.

41. The method of claim 40 wherein the peak plasma concentrations do not exceed 20 ng/ml.

42. The method of claim 40 wherein the peak plasma concentrations do not exceed 10 ng/ml.

43. The method of claim 31 or 36 wherein the peak plasma concentrations do not exceed 26 ng/ml.
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