METHODS FOR TREATING CHOLESTATIC PRURITUS
Methods of treating pruritus, including cholestatic pruritus, particularly cholestatic pruritus in primary biliary cholangitis comprising administration of the compound or a pharmaceutically acceptable salt thereof, are disclosed.
1 - 13 . (canceled)
14 . A method of treatment of cholestatic pruritus in primary biliary cholangitis in a human in need thereof comprising administering to said human the compound
or a pharmaceutically acceptable salt thereof, wherein the compound is administered in an amount of approximately 40 mg, twice daily.
15 . A method of treatment according to claim 14 , wherein such administration results in improvement in itch.
16 . The method of treatment according to claim 14 wherein the compound is administered orally.
17 . The method of treatment according to claim 14 wherein the compound is:
18 . The method of treatment according to claim 14 wherein said improvement in itch is demonstrated by a mean difference from placebo in mean change from baseline Monthly Itch Score of at least −0.5.
19 . The method of treatment according to claim 14 wherein said improvement in itch is demonstrated by a mean difference from placebo in mean change from baseline Monthly Itch Score of at least −0.9.
20 . The method of treatment according to claim 14 wherein the treatment period is at least 12 weeks in duration.
21 . A method of treatment of cholestatic pruritus in primary biliary cholangitis in a human in need thereof comprising administering to said human the compound
or a pharmaceutically acceptable salt thereof, wherein the compound is administered twice daily, and wherein such administration results in improvement in itch.