Medicine combinations and treatment of restless leg syndrome
Inventors
Assignees
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Publication Number
US-12064423-B2
Publication Date
2024-08-20
Expiration Date
Abstract
Embodiments disclosed herein describe, amongst other things, dosage forms, compounds, compositions, pharmaceutical compositions that can be used in the treatment of, for example, restless leg syndrome.
Core Innovation
The invention relates to treating restless leg syndrome or symptoms thereof in a subject by administering an oral pharmaceutical dosage form consisting of dextromethorphan, or a pharmaceutically acceptable salt thereof, quinidine, or a pharmaceutically acceptable salt thereof, and morphine, or a pharmaceutically acceptable salt thereof. The subject treatment is directed to the clinical context of restless leg syndrome symptoms, including augmentation of restless leg syndrome.
The invention further encompasses methods directed to increasing sleep in a subject with restless leg syndrome using the same oral pharmaceutical dosage form components: dextromethorphan, quinidine, and morphine, or pharmaceutically acceptable salts thereof. The described composition can include a constrained morphine:dextromethorphan:quinidine weight ratio, including about 1:1:1 (wt:wt:wt).
The document emphasizes that the combination of an NMDA antagonist component with a CYP2D6 inhibitor component and an opioid agonist component provides unexpected advantages compared with one- or two-drug regimens, including improved efficacy at reduced opioid doses, potential longer duration, reduced tolerance, and reduced side effects associated with opioid exposure. Example outcomes are described where administering quinidine/oxycodone/dextromethorphan relieved restless leg syndrome sensations and where adding dextromethorphan and quinidine to a bc-opioid agonist regimen resulted in opioid dose reduction and significant symptom relief, with a reported response rate across treated subjects.
Claims Coverage
The independent claims cover methods for treating restless leg syndrome (or symptoms thereof) and for increasing sleep in a subject with restless leg syndrome using an oral pharmaceutical dosage form that consists of dextromethorphan, quinidine, and morphine. Across the independent claim set, the inventive structure is defined by three included active components in the oral dosage form, with dependent claims further specifying an about 1:1:1 (wt:wt:wt) weight ratio and an augmentation-of-restless-leg-syndrome patient context.
Oral pharmaceutical dosage form consisting of dextromethorphan, quinidine, and morphine for treating restless leg syndrome
Administering to the subject an oral pharmaceutical dosage form consisting of dextromethorphan, or a pharmaceutically acceptable salt thereof, quinidine, or a pharmaceutically acceptable salt thereof, and morphine, or a pharmaceutically acceptable salt thereof.
Oral pharmaceutical dosage form consisting of dextromethorphan, quinidine, and morphine for increasing sleep in restless leg syndrome
Administering to the subject an oral pharmaceutical dosage form consisting of dextromethorphan, or a pharmaceutically acceptable salt thereof, quinidine, or a pharmaceutically acceptable salt thereof, and morphine, or a pharmaceutically acceptable salt thereof to increase sleep in a subject with restless leg syndrome.
Overall claim coverage centers on oral dosage forms that consist of dextromethorphan, quinidine, and morphine, with claimed clinical aims of treating restless leg syndrome (or symptoms thereof) and increasing sleep. Dependent claims further narrow use to augmentation of restless leg syndrome and define an about 1:1:1 (wt:wt:wt) weight ratio among morphine, dextromethorphan, and quinidine.
Stated Advantages
Improved efficacy at reduced opioid doses.
Potentially longer duration.
Lower tolerance.
Reduced side effects associated with opioid exposure.
Relief of restless leg syndrome sensations.
Significant symptom relief when added to a bc-opioid agonist regimen, with reduced opioid dose.
Documented Applications
Relieving restless leg syndrome sensations in subjects treated with a combination including quinidine, an opioid such as oxycodone, and dextromethorphan.
Treating augmentation of restless leg syndrome by administering the oral pharmaceutical dosage form consisting of dextromethorphan, quinidine, and morphine (or pharmaceutically acceptable salts).
Increasing sleep in a subject with restless leg syndrome using the oral pharmaceutical dosage form consisting of dextromethorphan, quinidine, and morphine.
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