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-10278952-B2
Publication Date
2019-05-07
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 is directed to a method of treating pruritus by administering 3-[(3aR,4R,5S,7aS)-5-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-4-(4-fluorophenyl)-1,3,3a,4,5,6,7,7a-octahydroisoindol-2-yl]cyclopent-2-en-1-one (serlopitant) or a pharmaceutically acceptable salt, solvate or polymorph thereof to a patient in need of treatment. The pruritus contexts explicitly include pruritus induced by a medication and pruritus associated with aging.
The document describes serlopitant use in medication-induced pruritus treatment using therapeutically effective amounts administered to a patient in need. It further describes dosing regimens including loading and maintenance dosing schedules, and dosing timing such as bedtime dosing with once daily administration.
The document also describes pharmaceutical compositions for administration in multiple forms, including oral tablets and capsules, as well as topical and transdermal formulations. The invention additionally supports serlopitant in combination therapy with additional antipruritic agents selected from defined classes, and describes formulation approaches including permeation enhancers and excipients for topical or transdermal delivery.
Claims Coverage
The patent provides two independent method claims covering administering serlopitant or a pharmaceutically acceptable salt, solvate, or polymorph for two pruritus categories, for a total of 2 independent claims. Across the dependent claim sets, the coverage includes route of administration, dosage options, dosing schedules, treatment duration thresholds, and optional combination with additional antipruritic agents.
Treating medication-induced pruritus with serlopitant
Administering to a patient in need of treatment a therapeutically effective amount of serlopitant or a pharmaceutically acceptable salt, solvate or polymorph, to treat pruritus induced by a medication.
Treating aging-associated pruritus with serlopitant
Administering to a patient in need of treatment a therapeutically effective amount of serlopitant or a pharmaceutically acceptable salt, solvate or polymorph, to treat pruritus associated with aging.
The claim coverage centers on serlopitant administration for medication-induced pruritus and aging-associated pruritus, with dependent provisions specifying administration routes, therapeutically effective dose ranges, dosing frequency and schedules, minimum treatment durations, and optional co-administration with additional antipruritic agent classes.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treatment of pruritus induced by a medication.
Treatment of pruritus associated with aging.
Use of serlopitant as a sleep aid in connection with sleep problems/disorders such as insomnia.
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