Use of NK-1 receptor antagonists in pruritus
Inventors
Zhang, Xiaoming • Schnipper, Edward F. • Perlman, Andrew J. • Larrick, James W.
Assignees
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Publication Number
US-9968588-B2
Publication Date
2018-05-15
Expiration Date
Abstract
The invention relates to methods for treating pruritus with NK-1 receptor antagonists such as serlopitant. The invention further relates to pharmaceutical compositions comprising NK-1 receptor antagonists such as serlopitant. In addition, the invention encompasses treatment of a pruritus-associated condition with serlopitant and an additional antipruritic agent, and the use of serlopitant as a sleep aid, optionally in combination with an additional sleep-aiding agent.
Core Innovation
The invention relates to a method of treating pruritus associated with a kidney disorder by administering a therapeutically effective amount of serlopitant, including a pharmaceutically acceptable salt, solvate, or polymorph thereof, to a patient in need of treatment. The method is directed to patient populations in which pruritus is associated with kidney disorders.
The invention further frames the treatment using administration timing and dosing paradigms for serlopitant, including administering at bedtime and using dosing schedules such as once daily, once every other day, once every third day, once every fourth day, or once per week. In addition, the invention describes a loading dose concept relative to therapeutically effective maintenance dosing, including loading doses that are 2x, 3x, 4x, or 5x larger than maintenance doses.
The invention additionally supports use of serlopitant for kidney-disorder-associated pruritus across specified kidney disorders, including diabetic nephropathy, glomerulonephritis, chronic kidney disease, chronic kidney failure, end-stage kidney disease, and uremia. The method also includes optional combination therapy in which one or more additional antipruritic agents are administered.
Claims Coverage
The provided material identifies one independent claim and describes its main inventive features, with dependent refinements covering kidney-disorder subtypes, serlopitant salt forms, route/timing constraints, dosing amounts and schedules, loading versus maintenance relationships, and optional combination with additional antipruritic agents.
Serlopitant for kidney-disorder-associated pruritus treatment
A method of treating pruritus associated with a kidney disorder by administering a therapeutically effective amount of serlopitant or a pharmaceutically acceptable salt, solvate or polymorph thereof to a patient in need of treatment.
Bedtime administration and specified dosing schedules
The method includes administering serlopitant at bedtime and includes dosing schedules selected from daily, every other day, every third day, every fourth day, or once per week.
Quantitative loading dose versus maintenance dose relationship
The method further specifies that at least one loading dose is 2x, 3x, 4x, or 5x larger than at least one therapeutically effective maintenance dose.
Kidney-disorder indication narrowed to specified conditions
The method of claim 1 is applied to kidney disorders selected from diabetic nephropathy, glomerulonephritis, chronic kidney disease, chronic kidney failure, end-stage kidney disease, or uremia.
Optional combination with additional antipruritic agents
The method of claim 1 further includes administering one or more additional antipruritic agents.
Across the provided independent claim and its dependent refinements, the claim coverage centers on administering serlopitant, including salt, solvate or polymorph forms, to treat pruritus associated with kidney disorders, with further control over bedtime administration, enumerated dosing schedules, loading versus maintenance dose ratios, narrowed kidney-disorder subtypes, and optional combination therapy with additional antipruritic agents.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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