Use of NK-1 receptor antagonist serlopitant in pruritus
Inventors
Zhang, Xiaoming • Schnipper, Edward F. • Perlman, Andrew J. • Larrick, James W.
Assignees
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Publication Number
US-10278953-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 relates to treating pruritus by administering serlopitant or a pharmaceutically acceptable salt, solvate or polymorph thereof to a patient in need of treatment. The pruritus is associated with a neuropathy, including neurogenic pruritus, and the description includes a chemical/biological rationale involving substance P and NK-1 receptors.
The described compositions and regimens cover administering serlopitant for acute pruritus and chronic pruritus, including oral tablet administration and also topical and transdermal administration. The document describes dosing schedules such as bedtime dosing and intermittent dosing schedules, as well as loading-dose and maintenance-dose concepts for chronic therapy.
The document also describes treatment using serlopitant in combination therapy with one or more additional antipruritic agents selected from enumerated drug classes. A further described use case is serlopitant as a sleep aid in sleep disorders, including insomnia, circadian rhythm disorders, parasomnias, and sleep apnea, including the possibility of co-administration with additional sleep-aiding agents.
Claims Coverage
The partial content provides two independent claims that cover methods of treating pruritus: one directed to pruritus associated with a neuropathy and one directed to neurogenic pruritus. Across the claim sets, multiple inventive features are specified, including the target condition association, the active agent identity, and several dose, regimen, route, and combination constraints.
Treating pruritus associated with neuropathy with serlopitant
A method of treating pruritus associated with a neuropathy by administering a therapeutically effective amount of serlopitant or a pharmaceutically acceptable salt, solvate or polymorph thereof to a patient in need of treatment.
Treating neurogenic pruritus with serlopitant
A method of treating neurogenic pruritus by administering a therapeutically effective amount of serlopitant or a pharmaceutically acceptable salt, solvate or polymorph thereof to a patient in need of treatment.
Therapeutically effective serlopitant dosage ranges
Administering a therapeutically effective amount of serlopitant in a dosage range of about 0.1 mg to about 30 mg or about 1 mg to about 7.5 mg.
Specified daily or intermittent dosing schedules
Administering serlopitant on a dosing schedule of once daily, once every other day, once every third day, once every fourth day, or once a week.
Loading dose to maintenance dose ratio
Specifying that at least one loading dose is a multiple of the at least one therapeutically effective maintenance dose.
Oral or dermal/transdermal administration options
Administering serlopitant orally and, for further narrowing, administering serlopitant dermally or transdermally.
Neuropathy and neurogenic pruritus subtypes
Defining the neuropathy to include peripheral and small fiber peripheral neuropathy, post-zoster neuralgia, vulvodynia, polyneuropathy, nerve irritation or pinched nerve, brachioradial pruritus, notalgia paresthetica, multiple sclerosis, and neuropathy associated with underperfusion or infarction or with a tumor or abscess involving the brain or the spinal cord.
Combination therapy with additional antipruritic agents
Administering one or more additional antipruritic agents, where the additional antipruritic agents are selected from a group including antihistamines, corticosteroids, immunomodulators, immunosuppressants, antidepressants, anticonvulsants, kappa opioid receptor agonists, opioid receptor antagonists, counterirritants, cooling agents, and local anesthetics.
Across the independent claims, the coverage centers on administering serlopitant for neuropathy-associated pruritus and neurogenic pruritus, further refined by dosage ranges, dosing schedules, loading-to-maintenance dose multiples, administration routes, neuropathy subtypes, and combination therapy with enumerated antipruritic agent classes.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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