(AU2018214098) Methods for treating pruritus 机翻标题: 暂无翻译,请尝试点击翻译按钮。

源语言标题
(AU2018214098) Methods for treating pruritus
公开号/公开日
AU2018214098AU2018214098 / 2019-04-182018-08-30
申请号/申请日
AU2018214098 / 2018-08-09
发明人
SCIASCIA THOMAS;
申请人
TREVI THERAPEUTICS;
主分类号
IPC分类号
A01N-043/42 A61K-031/485 A61P-025/00
摘要
(AU2018214098) METHODS FOR TREATING PRURITUS The present invention relates to methods for treating pruritus with anti-pruritic compositions.
机翻摘要
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地址
代理人
(AU2018214098) Spruson & Ferguson ([AU])
代理机构
;
优先权号
2012US-13715625 2012US-61737488 2013AU-0359017 2013WO-US75096 2018AU-0214098
主权利要求
(AU2018214098) 1. A method of treating uremic pruritus comprising administering an effective amount of an antipruritus agent to a subject in need of such treatment, wherein the anti-pruritus agent is nalbuphine or a pharmaceutically acceptable salt or ester thereof. 2. The method of claim 1, wherein the patient is under dialysis treatment. 3. The method of claim 1, wherein the patient has a chronic kidney disease or a reduced renal function. 4. The method of claim 1, wherein the anti-pruritus agent is administered at an initial oral dose of from about 15 mg to about 60 mg twice a day and then titrated to an effective dose. 5. The method of claim 1, wherein the anti-pruritus agent is administered at an initial oral dose of about 30 mg twice a day and then titrated to an effective dose. 6. The method of claim 1, wherein the anti-pruritus agent is administered at an initial dose of from about 15 mg to about 60 mg once a day and then titrated to an effective dose. 7. The method of claim 1, wherein the anti-pruritus agent is administered at an initial dose of from about 15 mg to about 60 mg twice a day or once a day for about 3 days and then titrated to an effective dose at about 15 mg to about 60 mg increment. 8. . The method of claim 1, wherein the anti-pruritus agent is administered at an initial dose of about 30 mg twice a day for about 2-3 days and then titrated to an effective dose at about 30 mg increment. 9. The method of claim 1, wherein the maximum dose of the anti-pruritus agent is about 180 mg when said agent is administered to a patient twice a day, or 360 mg when said agent is administered to a patient once a day. 10. The method of claim 1, wherein the maximum dose of the anti-pruritus agent is about 360 mg when said agent is administered to a subject twice a day. 11. The method of claim 1, wherein the maximum dose of the anti-pruritus agent is about 240 mg when said agent is administered to a subject twice a day. 12. The method of claim 1, wherein the anti-pruritus agent is administered from about 60 mg to about 180 mg twice daily. 13. The method of claim 1, wherein the anti-pruritus agent is administered from about 60 mg to about 120 mg twice daily. 14. The method of claim 1, wherein the anti-pruritus agent is administered with an AM dosage and a PM dosage and wherein the PM dosage is higher than the AM dosage, or vice versa. 15. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the patient a mean Cmax of from about 1.9 ng/mL to about 102 ng/mL. 16. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the patient a mean Cmax of from about 30 ng/mL to about 60 ng/mL. 17. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the patient an AUC(o-.) of from about 37 ng•hr/mL to about 910 ng•hr/mL. 18. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the patient an AUC(o-co) of from about 200 ng•hr/mL to about 500 ng•hr/mL. 19. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the patient an AUC(o-.) of from about 70 ng•hr/mL to about 210 ng•hr/mL. 20. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the subject a mean AUCtaa from about 221.68 h*ng/mL to about 621.79 h*ng/mL. 21. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the subject a mean AUCtaa from about 43.2 h*ng/mL to about 769.99 h*ng/mL. 22. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the subject a mean AUCtaa from about 40 h*ng/mL to about 800 h*ng/mL. 23. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the subject a mean Cmax of from about 24 ng/mL to about 71 ng/mL. 24. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the subject a mean Cmax of from about 5 ng/mL to about 85 ng/mL. 25. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the subject a mean Cmax of from about 6.28 ng/mL to about 82.78 ng/mL. 26. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the subject a pK release profile with the characteristics of a) a mean Cmax from about 24.78 ng/mL to about 70.33 ng/mL and b) a mean AUCtaa from about 221.68 h*ng/mL to about 621.79 h*ng/mL. 27. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the subject a median Tmax of from about 5 h to about 6 h. 28. The method of claim 1, wherein the anti-pruritus agent is in an extended release oral dosage form and the administration provides in the subject a median Tmax of from about 4 h to about 6 h. 29. The method of claim 1, wherein the anti-pruritus agent is at least 50% dialyzable when the patient is under the treatment of dialysis. 30. The method of claim 1, wherein one or more of the metabolites of the anti-pruritus agent do not have detectable anti-pruritus activity. 31. The method of claim 1, wherein at least one metabolite of the anti-pruritus agent is at least 50% dialyzable when the anti-pruritus agent is administered to a patient under dialysis treatment. 32. The method of claim 1, wherein the anti-pruritus agent is not administered in combination with a second anti-pruritus agent. 33. A method of treating uremic pruritus comprising administering an effective amount of an antipruritus agent to a human patient in need of such treatment, wherein the anti-pruritus agent is nalbuphine or a pharmaceutically acceptable salt or ester thereof and wherein the anti-pruritus agent is in an extended release oral dosage form. 34. The method of claim 33, wherein the administration provides in the patient a pK release profile with the characteristics of a) a mean Cmax from about 1.9 ng/mL to about 102 ng/mL, and b) AUC(oco) from about 37 ng•hr/mL to about 910 ng•hr/mL. 35. The method of claim 33, wherein the administration provides in the patient a pK release profile with the characteristics of a) a mean Cmax from about 1.9 ng/mL to about 102 ng/mL, and b) AUC(oco) from about 200 ng•hr/mL to about 500 ng•hr/mL. 36. The method of claim 33, wherein the administration provides in the patient a pK release profile with the characteristics of a) a mean Cmax from about 1.9 ng/mL to about 102 ng/mL, and b) AUC(oco) from about 70 ng•hr/mL to about 210 ng•hr/mL. 37. The method of claim 33, wherein the administration provides in the patient a pK release profile with the characteristics of a) a mean Cmax from about 30 ng/mL to about 60 ng/mL, and b) AUC(oco) from about 37 ng•hr/mL to about 910 ng•hr/mL. 38. The method of claim 33, wherein the administration provides in the patient a pK release profile with the characteristics of a) a mean Cmax from about 30 ng/mL to about 60 ng/mL, and b) AUC(oco) from about 200 ng•hr/mL to about 500 ng•hr/mL. 39. The method of claim 33, wherein the administration provides in the patient a pK release profile with the characteristics of a) a mean Cmax from about 30 ng/mL to about 60 ng/mL, and b) AUC(oco) from about 70ng•hr/mL to about 210 ng•hr/mL. 40. The method of claim 33, wherein the anti-pruritus agent is administered at an initial dose of about 15 mg to about 60 mg twice a day and then titrated to an effective dose. 41. The method of claim 33, wherein the anti-pruritus agent is administered at an initial dose of about 15 mg to about 60 mg once a day and then titrated to an effective dose. 42. The method of claim 33, wherein the anti-pruritus agent is administered at an initial dose of about 15 mg to about 60 mg twice a day or once a day for about 3 days and then titrated to an effective dose at about 15 mg to about 60 mg increment. 43. The method of claim 33, wherein the maximum dose of the anti-pruritus agent is about 180 mg when said agent is administered to a patient twice a day, or 360 mg when said agent is administered to a patient once a day. 44. The method of claim 33, wherein the anti-pruritus agent is administered with an AM dosage and a PM dosage and wherein the PM dosage is higher than the AM dosage, or vice versa. 45. The method of claim 33, wherein the anti-pruritus agent is at least 50% dialyzable when the patient is under the treatment of dialysis. 46. The method of claim 33, wherein the anti-pruritus agent is administered in a formulation comprising nalbuphine hydrochloride, mannitol, hydroxypropyl cellulose, locust bean gum, xanthan gum, calcium sulfate dihydrate and magnesium stearate. 47. The method of claim 33, wherein the administration provides in the patient a mean Cmax from about ng/mL to about 102 ng/mL. 48. A method of treating uremic pruritus comprising administering an effective amount of an antipruritus agent to a human patient in need of such treatment, wherein the anti-pruritus agent is nalbuphine or a pharmaceutically acceptable salt or ester thereof and wherein the anti-pruritus agent is in an extended release dosage form. 49. Use of an effective amount of an anti-pruritus agent in the manufacture of a medicament for treating uremic pruritus in a subject in need of such treatment, wherein the anti-pruritus agent is nalbuphine or a pharmaceutically acceptable salt or ester thereof. 50. Use of an effective amount of an anti-pruritus agent in the manufacture of a medicament for treating uremic pruritus in a human patient in need of such treatment, wherein the anti-pruritus agent is nalbuphine or a pharmaceutically acceptable salt or ester thereof and wherein the antipruritus agent is in an extended release oral dosage form. 51. Use of an effective amount of an anti-pruritus agent in the manufacture of a medicament for treating uremic pruritus in a human patient in need of such treatment wherein the anti-pruritus agent is nalbuphine or a pharmaceutically acceptable salt or ester thereof and wherein the antipruritus agent is in an extended release dosage form. Trevi Therapeutics, Inc. Patent Attorneys for the Applicant/Nominated Person SPRUSON & FERGUSON
法律状态
GRANTED
专利类型码
B2A1
国别省市代码
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