Use of NK-1 receptor antagonist serlopitant in pruritus

Inventors

Zhang, Xiaoming • Schnipper, Edward F. • Perlman, Andrew J. • Larrick, James W.

Assignees

Vyne Therapeutics Inc

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 methods of treating pruritus associated with psoriasis by administering serlopitant, or a pharmaceutically acceptable salt, solvate, or polymorph thereof, to a patient in need of treatment. The described pruritus context includes acute or chronic pruritus associated with psoriasis.

The invention further relates to methods of treating pruritus associated with dermatitis or eczema by administering serlopitant, or a pharmaceutically acceptable salt, solvate, or polymorph thereof, to a patient in need. The described dosing concepts include chronic dosing regimens and loading/maintenance schedule concepts, including administration timing such as bedtime dosing and interval schedules such as alternate-day and longer interval schedules.

In addition to systemic administration, the described invention includes pharmaceutical compositions and topical formulations for delivering serlopitant, including tablet or capsule formulations and topical, dermal, or transdermal formulations. The document includes reference to permeation enhancers in topical formulations and describes in vitro human skin permeation using Franz diffusion cells, including skin penetration and skin retention outcomes for topical formulations.

The document also describes optional combination therapy in which serlopitant is administered together with one or more additional antipruritic agents selected from various therapeutic categories, and it provides an additional use of serlopitant as a sleep aid for sleep disorders such as insomnia, including optional combination with additional sleep-aiding agents. The described clinical context includes a Phase II clinical trial concept with efficacy and safety endpoints including VAS and DLQI.

Claims Coverage

The provided claims include two independent claims. Across these independent claims, the core inventive features focus on administering serlopitant, or a pharmaceutically acceptable salt, solvate, or polymorph, in a therapeutically effective amount to treat specific pruritus indications.

Both independent claims center on administering serlopitant, or a pharmaceutically acceptable salt, solvate, or polymorph, in a therapeutically effective amount to treat pruritus tied to specific dermatologic conditions. Dependent claims refine dosage, administration route including oral and topical, dermal, or transdermal, and treatment scheduling, and add optional combination administration with enumerated additional antipruritic agent categories.

Stated Advantages

Documented Applications