Use of a phosphodiesterase 10 inhibitor for the treatment of tourette syndrome
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Publication Number
US-11883385-B2
Publication Date
2024-01-30
Expiration Date
Abstract
Provided herein are methods of treating Tourette Syndrome in a subject in need thereof by administering to the subject compositions comprising a PDE10 inhibitor. Also disclosed are crystalline solid forms of the compound of Formula I and uses thereof:
Core Innovation
The invention describes a method of treating Tourette Syndrome by administering a composition that includes a therapeutically effective amount of a first therapeutic agent. The therapeutic agent is a compound of Formula I or a pharmaceutically acceptable salt thereof, and the approach is positioned for patients with Tourette Syndrome with patient tic severity inclusion based on named clinical measures.
The described method incorporates patient tic severity thresholds using the Yale Global Tic Severity Scale, including a total tic score threshold at the start of treatment. The disclosure also frames treatment in relation to prior-therapy context, including typical antipsychotics, psychostimulants, and alpha-2 antagonists, and efficacy and safety are assessed using named clinical and patient-reported instruments including YGTSS total tic score measures and CGI/PGlC-related measures.
The disclosure also supports the therapeutic agent with solid-form and characterization information for a crystalline free-base solid form of Formula I. The crystalline solid form is described using DSC melting point information and XRPD/DSC signatures shown in figures, and pharmaceutical compositions and capsule formulations for administering the compound are described with excipient lists and related formulation characterization and stability/solubility data.
Claims Coverage
The relevant independent claim provides coverage for a method of treating Tourette Syndrome by administering a therapeutically effective amount of a compound of Formula I or a pharmaceutically acceptable salt. Across the disclosed dependents, five inventive features refine treatment eligibility, administration characteristics, dosage amounts, and composition/formulation elements.
Treating Tourette Syndrome with Formula I therapeutic agent
Administering to a subject in need thereof a therapeutically effective amount of a composition comprising a first therapeutic agent, wherein the therapeutic agent is a compound of Formula I or a pharmaceutically acceptable salt thereof.
Baseline tic severity threshold using Yale Global Tic Severity Scale
The method includes that the subject’s total tic score at the start of treatment is at least 22 on the Yale Global Tic Severity Scale.
Oral unit-dose administration
The method specifies that the therapeutic is administered by oral administration as a unit dose.
Defined dosage amount range
The method specifies administering the therapeutic at a dosage amount of about 2.5 mg to about 10 mg.
Composition including specified inactive agents
The method includes a composition wherein inactive agents are selected from a listed group including mannitol, microcrystalline cellulose, sodium starch glycolate, sucrose monopalmitate, hydroxypropyl methylcellulose, colloidal silicon dioxide, and sodium stearyl fumarate.
Claim coverage is centered on treating Tourette Syndrome with a therapeutically effective amount of a Formula I compound or salt, with refinements for baseline tic severity using the Yale Global Tic Severity Scale, oral unit-dose administration, defined dosage amount range, and specified inactive-agent excipient lists for the composition.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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