Claims
- 1. A method of treating pain comprising administering to a human patient in need of such treatment
(a) from about 3 to about 8 mg of nalbuphine or a pharmaceutically acceptable salt thereof or a prodrug therefor, said salt or prodrug being administered in an amount that produces in the human patient the same blood concentration of nalbuphine as would administration of from about 3 to about 8 mg of nalbuphine; and (b) from about 0.2 to about 0.8 mg of an opioid antagonist selected from the group consisting of naloxone, naltrexone, nalmefene, pharmaceutically acceptable salts thereof and prodrugs therefor; said salt or prodrug being administered in an amount that produces in the human patient the same blood concentration of opioid antagonist as would administration of from about 0.2 to about 0.8 mg of said opioid antagonist.
- 2. The method of claim 1 in which from about 3.5 to about 7 mg of nalbuphine is administered, or said nalbuphine salt or prodrug is administered in an amount that produces in the human patient the same blood concentration of nalbuphine as would administration of from about 3.5 to about 7 mg of nalbuphine.
- 3. The method of claim 1 in which about 5 mg of nalbuphine is administered, or said nalbuphine salt or prodrug is administered in an amount that produces in the human patient the same blood concentration of nalbuphine as would administration of about 5 mg of nalbuphine.
- 4. The method of claim 1 in which about 0.4 mg of the opioid antagonist is administered, or said opioid antagonist salt or prodrug is administered in an amount that produces in the human patient the same blood concentration of the opioid antagonist as would administration of about 0.4 mg of the opioid antagonist.
- 5. The method of claim 2 in which about 0.4 mg of the opioid antagonist is administered, or said opioid antagonist salt or prodrug is administered in an amount that produces in the human patient the same blood concentration of the opioid antagonist as would administration of about 0.4 mg of the opioid antagonist.
- 6. The method of claim 3 in which about 0.4 mg of the opioid antagonist is administered, or said opioid antagonist salt or prodrug is administered in an amount that produces in the human patient the same blood concentration of the opioid antagonist as would administration of about 0.4 mg of the opioid antagonist.
- 7. The method of claim 1 in which the opioid antagonist comprises naloxone, a pharmaceutically acceptable salt thereof or a prodrug therefor.
- 8. The method of claim 2 in which the opioid antagonist comprises naloxone, a pharmaceutically acceptable salt thereof or a prodrug therefor.
- 9. The method of claim 3 in which the opioid antagonist comprises naloxone, a pharmaceutically acceptable salt thereof or a prodrug therefor.
- 10. The method of claim 4 in which the opioid antagonist comprises naloxone, a pharmaceutically acceptable salt thereof or a prodrug therefor.
- 11. The method of claim 5 in which the opioid antagonist comprises naloxone, a pharmaceutically acceptable salt thereof or a prodrug therefor. The method of claim 1 wherein the pain comprises inflammatory pain.
- 12. The method of claim 6 in which the opioid antagonist comprises naloxone, a pharmaceutically acceptable salt thereof or a prodrug therefor.
- 13. The method of claim 1 wherein the pain comprises inflammatory pain.
- 14. The method of claim 1 in which the nalbuphine and opioid antagonist, and/or salts or prodrugs of either, are administered within eight hours of one another.
- 15. The method of claim 1 in which the nalbuphine and opioid antagonist, and/or salts or prodrugs of either, are administered within two hours of one another.
- 16. The method of claim 1 in which the nalbuphine and opioid antagonist, and/or salts or prodrugs of either, are administered within 15 minutes of one another.
- 17. The method of claim 1 in which the nalbuphine and opioid antagonist, and/or salts or prodrugs of either, are administered together at substantially the same time.
- 18. The method of claim 1 comprising sequential administration of nalbuphine and the opioid antagonist, and/or salts or prodrugs of either.
- 19. The method of claim 1 comprising parenteral administration of at least one of the nalbuphine and opioid antagonist, and/or salts or prodrugs of either.
- 20. The method of claim 1 comprising intravenous administration of at least one of the nalbuphine and opioid antagonist, and/or salts or prodrugs of either.
- 21. A method of treating neuropathic pain comprising administering to a human patient in need of such treatment (a) nalbuphine or a pharmaceutically acceptable salt of nalbuphine or a prodrug of nalbuphine, and (b) an opioid antagonist selected from the group consisting of naloxone, naltrexone, nalmefene, pharmaceutically acceptable salts thereof, and prodrugs therefor.
- 22. The method of claim 21 in which the opioid antagonist comprises naloxone, a pharmaceutically acceptable salt thereof or a prodrug therefor.
- 23. The method of claim 21 wherein the amount of said opioid antagonist administered is at least 10-15-fold less than the amount of the nalbuphine administered.
- 24. A pharmaceutical composition comprising an amount of nalbuphine or a pharmaceutically effective salt thereof or prodrug therefor, effective to treat neuropathic pain in a human patient, and a pain-relieving enhancing amount of an opioid antagonist selected from the group consisting of naloxone, naltrexone and nalmefene, pharmaceutically acceptable salts thereof and prodrugs therefor.
- 25. A pharmaceutical composition comprising (a) from about 3 to about 8 mg of nalbuphine or a pharmaceutically acceptable salt or prodrug of nalbuphine, said nalbuphine salt or prodrug being present in an amount that produces in the human patient the same blood concentration of nalbuphine as would administration of from 3 to 8 mg of nalbuphine; and (b) from about 0.2 to about 0.8 mg of an opioid antagonist selected from the group consisting of naloxone, naltrexone, nalmefene, pharmaceutically acceptable salts thereof, and prodrugs therefor; said salt or prodrug being present in an amount that, when administered to said human patient, produces in the patient the same blood concentration of opioid antagonist as would administration of from about 0.2 to about 0.8 mg of said opioid antagonist.
- 26. The pharmaceutical composition of claim 25 comprising from about 3.5 to about 7 mg of nalbuphine or a pharmaceutically acceptable salt of nalbuphine in an amount that produces, when administered to said human patient, the same blood concentration of nalbuphine as would administration of about 3.5 to about 7 mg of nalbuphine.
- 27. The pharmaceutical composition of claim 25 comprising about 5 mg of nalbuphine or a pharmaceutically acceptable salt or prodrug of nalbuphine in amount that produces, when administered to said human patient, the same blood concentration of nalbuphine as would administration of about 5 mg of nalbuphine.
- 28. The pharmaceutical composition of claim 25 comprising about 0.4 mg of the opioid antagonist or a pharmaceutically acceptable salt thereof or a prodrug therefor, in an amount that produces, when administered to said human patient, the same blood concentration of said opioid antagonist as would administration of about 0.4 mg of said opioid antagonist.
- 29. The pharmaceutical composition of claim 26 comprising about 0.4 mg of the opioid antagonist or a pharmaceutically acceptable salt thereof or a prodrug therefor, in an amount that produces, when administered to said human patient, the same blood concentration of said opioid antagonist as would administration of about 0.4 mg of said opioid antagonist.
- 30. The pharmaceutical composition of claim 27 comprising about 0.4 mg of the opioid antagonist or a pharmaceutically acceptable salt thereof or a prodrug therefor, in an amount that produces, when administered to said human patient, the same blood concentration of said opioid antagonist as would administration of about 0.4 mg of said opioid antagonist.
- 31. The pharmaceutical composition of claim 25 wherein the composition is formulated for treating inflammatory pain.
- 32. The pharmaceutical composition of claim 25 wherein the composition is formulated for treating neuropathic pain.
- 33. The pharmaceutical composition of claim 25 wherein the composition is formulated for treating neuropathic pain. A pharmaceutical composition comprising (a) nalbuphine, a pharmaceutically acceptable salt of nalbuphine or a prodrug of nalbuphine and (b) an opioid antagonist selected from naloxone, naltrexone, and nalmefene, pharmaceutically acceptable salts thereof, and prodrugs therefor, wherein the weight ratio of ingredient (a) to ingredient (b) is from 16:1 to 4:1, and wherein, if either ingredient is in the form of a salt thereof or a prodrug therefor, said ingredient is present in an amount that produces that produces, when administered to a human patient, the same blood concentration of nalbuphine or said opioid antagonist as would administration of about 5 mg of nalbuphine or about 0.4 mg of said opioid antagonist, respectively.
- 34. The method of claim 1 in which from about 3 to about 8 mg of nalbuphine is administered, and the opioid antagonist is selected from the group consisting of naloxone, naltrexone, and nalmefene.
- 35. The method of claim 34 in which from about 3.5 to about 7 mg of nalbuphine is administered.
- 36. The method of claim 34 in which about 5 mg of nalbuphine is administered.
- 37. The method of claim 34 in which about 0.4 mg of the opioid antagonist is administered.
- 38. The method of claim 35 in which about 0.4 mg of the opioid antagonist is administered.
- 39. The method of claim 36 in which about 0.4 mg of the opioid antagonist is administered.
- 40. The method of claim 34 in which the opioid antagonist comprises naloxone.
- 41. The method of claim 35 in which the opioid antagonist comprises naloxone.
- 42. The method of claim 36 in which the opioid antagonist comprises naloxone.
- 43. The method of claim 42 in which about 0.4 mg of naloxone is administered.
- 44. The method of claim 34 wherein the pain comprises inflammatory pain.
- 45. The method of claim 34 wherein the pain comprises neuropathic pain.
- 46. The method of claim 34 in which the nalbuphine and opioid antagonist are administered within eight hours of one another.
- 47. The method of claim 34 in which the nalbuphine and opioid antagonist are administered within two hours of one another.
- 48. The method of claim 34 in which the nalbuphine and opioid antagonist are administered within 15 minutes of one another.
- 49. The method of claim 34 in which the nalbuphine and opioid antagonist are administered together at substantially the same time.
- 50. The method of claim 34 comprising sequential administration of nalbuphine and the opioid antagonist.
- 51. The method of claim 34 comprising parenteral administration of at least one of the nalbuphine and opioid antagonist.
- 52. The method of claim 34 comprising intravenous administration of at least one of the nalbuphine and opioid antagonist.
- 53. The method of claim 43 in which the nalbuphine and opioid antagonist are administered within 15 minutes of one another.
- 54. The method of claim 43 in which the nalbuphine and opioid antagonist are administered together at substantially the same time.
STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT
[0001] This invention was made with government support under Grant No. NR 03923 of the National Institutes of Health. The government has certain rights in this invention.
Provisional Applications (1)
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Number |
Date |
Country |
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60210367 |
Jun 2000 |
US |
Divisions (1)
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Number |
Date |
Country |
Parent |
09877669 |
Jun 2001 |
US |
Child |
10327508 |
Dec 2002 |
US |
Continuations (1)
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Number |
Date |
Country |
Parent |
10327508 |
Dec 2002 |
US |
Child |
10458499 |
Jun 2003 |
US |