TREATMENT OF UREMIC PRURITUS

1 . A method of treating uremic pruritus, comprising administering for at least a week to a patient in need thereof, a daily dose of at least about 120 mg of an anti-pruritus agent, wherein the anti-pruritus agent is nalbuphine or a pharmaceutically acceptable salt or ester thereof, and wherein after said treating the patient experiences a substantial reduction in itch compared to prior to said treating.

2 . The method of claim 1 , wherein about 60 mg of nalbuphine or a pharmaceutically acceptable salt or ester thereof is administered twice a day.

3 . The method of claim 1 , wherein about 120 mg of nalbuphine or a pharmaceutically acceptable salt or ester thereof is administered once a day.

4 . The method of claim 1 , wherein about 120 mg of nalbuphine or a pharmaceutically acceptable salt or ester thereof is administered twice a day.

5 . The method of claim 1 , wherein about 240 mg of nalbuphine or a pharmaceutically acceptable salt or ester thereof is administered once a day.

6 . The method of claim 1 , wherein said administering is for about 8 weeks, 10 weeks, 12 weeks, 24 weeks or 50 weeks.

7 . The method of claim 1 , wherein the patient has moderate or severe uremic pruritus.

8 . The method of claim 1 , wherein the patient is a patient with chronic kidney disease.

9 . The method of claim 1 , wherein the patient is a hemodialysis patient.

10 . The method of claim 1 , further comprising titrating the dose of the anti-pruritus agent for at least one week prior to said administering.

11 . The method of claim 1 , further comprising titrating the dose of the anti-pruritus agent for about 2 weeks prior to said administering.

12 . The method of claim 1 , further comprising titrating the dose of the anti-pruritus agent for about 7 to 30 days prior to said administering.

13 . The method of claim 1 , further comprising titrating the dose of the anti-pruritus agent for about 12 to 20 days prior to said administering.

14 . The method of claim 10 , wherein said titrating comprises administering ascending doses of the anti-pruritus agent until a steady state is achieved in the patient.

15 . The method of claim 10 , wherein said titrating comprises administering ascending doses of the anti-pruritus agent until an effective amount of 60 mg or 120 mg is achieved in the patient.

16 . The method of claim 10 , wherein said titrating further comprises administering an initial dose of about 15 mg once or twice a day.

17 . The method of claim 10 , wherein said titrating comprises administering an initial dose of about 30 mg once or twice a day.

18 . The method of claim 10 , wherein said titrating comprises administering the anti-pruritus agent in increments ranging from about 15 mg to about 30 mg.

19 . The method of claim 16 , wherein said administering twice a day is with an AM dosage and a PM dosage, wherein the PM dosage is higher than or the same as the AM dosage.

20 . The method of claim 10 , wherein the rate of adverse events after said titration is substantially the same as the rate of adverse events after administering a placebo for the same period of time.

21 . The method of claim 1 , wherein a patient with moderate or severe baseline itch prior to said treating experiences mild itch after said treating.

22 . The method of claim 1 , wherein after said treating the patient experiences a reduction of itch that is characterized by at least about a 30% decline in worst itching intensity Numerical Rating Scale (NRS) value.

23 . The method of claim 22 , wherein the reduction of itch is at least about a 40% decline in NRS value.

24 . The method of claim 22 , wherein the reduction of itch is at least about a 50% decline in NRS value.

25 . The method of claim 1 , wherein after said treating the patient experiences a reduction of itch that is characterized by at least about a 10% improvement in Skindex-10 total or subscale domain score.

26 . The method of claim 25 , wherein the reduction of itch is at least about a 20% improvement in Skindex-10 total or subscale domain score.

27 . The method of claim 25 , wherein the reduction of itch is at least about a 30% improvement in Skindex-10 total or subscale domain score.

28 . The method of claim 1 , wherein after said treating the patient experiences a reduction of itch that is characterized by at least about a 20% improvement in Itch Medical Outcomes Study (MOS) sleep scale.

29 . The method of claim 28 , wherein the reduction of itch is at least about a 30% improvement in Itch MOS sleep scale.

30 . The method of claim 28 , wherein the reduction of itch is at least about a 40% improvement in Itch MOS sleep scale.

31 . The method of claim 1 , wherein the rate of infection of the patient after said treating is lower than that of the patients prior to said treating.

32 . The method of claim 1 , further comprising administering at least one additional antipruritic drug.

33 . The method of claim 32 , wherein the at least one additional antipruritic drug is selected from the group consisting of antihistamines and corticosteroids.

34 . The method of claim 32 , wherein the anti-pruritus agent is in the form of an extended release oral dosage form.

35 . The method of claim 34 , 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.

36 . The method of claim 35 , wherein the daily dose of nalbuphine or a pharmaceutically acceptable salt or ester thereof is substantially the same during the administering.

37 . The method of claim 36 , wherein said administering is for about 12 weeks, 24 weeks or 50 weeks.

38 . The method of claim 36 , wherein the daily dose of nalbuphine or a pharmaceutically acceptable salt or ester is about 240 mg during the administering.

39 . The method of claim 1 , wherein the administering provides a steady state blood plasma concentration of between about 20 and 80 ng/mL.

40 . The method of claim 39 , wherein the steady state blood plasma concentration is between about 30 and 70 ng/mL.

41 . The method of claim 39 , wherein the daily dose of nalbuphine or a pharmaceutically acceptable salt or ester is about 240 mg.

42 . The method of claim 17 , wherein said administering twice a day is with an AM dosage and a PM dosage, wherein the PM dosage is higher than or the same as the AM dosage.

43 . The method of claim 37 , wherein the daily dose of nalbuphine or a pharmaceutically acceptable salt or ester is about 240 mg during the administering.

44 . The method of claim 40 , wherein the daily dose of nalbuphine or a pharmaceutically acceptable salt or ester is about 240 mg.