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Assignees
Member
VitalisVitalis develops infrastructure for integrating, resolving, and analyzing health data streams from multiple sources such as wearables, sensors, labs, and medical records to create a unified longitudinal health record. Initially focused on brain health and cumulative exposure monitoring, Vitalis emphasizes consent-driven, secure, and research-ready data practices. The platform is vendor-agnostic, supporting data portability, user privacy, and adaptability to high-stakes operational environments.
Vitalis develops infrastructure for integrating, resolving, and analyzing health data streams from multiple sources such as wearables, sensors, labs, and medical records to create a unified longitudinal health record. Initially focused on brain health and cumulative exposure monitoring, Vitalis emphasizes consent-driven, secure, and research-ready data practices. The platform is vendor-agnostic, supporting data portability, user privacy, and adaptability to high-stakes operational environments.
Publication Number
US-11013751-B2
Publication Date
2021-05-25
Expiration Date
Abstract
Provided are compositions and methods for treating multiple sclerosis (MS). One embodiment of the disclosed method entails orally administering to a MS patient a first amount of aspirin and a second amount of fumaric acid or an ester or a salt thereof. In some embodiments, the aspirin is administered at from about 80 mg to about 500 mg per day and the fumaric acid or ester or salt thereof is administered at about 360 mg per day.
Core Innovation
Disclosed is a dosage form for treatment of multiple sclerosis that includes an effective amount of aspirin and an effective amount of fumaric acid or an ester or a salt thereof, where the aspirin and the fumaric acid or the ester or the salt thereof are each individually formulated as enterically coated microspheres. The document further describes a capsule in which both individually enterically coated microsphere components are contained within the capsule shell.
The disclosure addresses the use of fumaric acid or fumarates in multiple sclerosis treatment, including treatment-associated flushing with dimethyl fumarate, and the need to improve fumarate exposure or reduce flushing severity while enabling dosing regimens. It reports that aspirin co-administration unexpectedly increases fumarate bioavailability and reduces flushing severity associated with dimethyl fumarate.
The document states that oral treatment regimens using concomitant aspirin and fumaric acid/fumarate, including dimethyl fumarate and monomethyl fumarate, can increase fumarate bioavailability and reduce flushing severity. It describes pharmacokinetic comparisons under fasting conditions and flushing assessments using a Global Flushing Severity Scale, together with formulation timing and capsule release coordination concepts involving enterically coated microspheres.
Claims Coverage
The partial content provides two independent claims. Across the independent claims, there are two principal inventive features: an enterically coated microsphere dosage form containing both aspirin and fumaric acid/ester/salt, and a capsule implementation where both components are individually enterically coated microspheres within the capsule shell.
Enterically coated microspheres dosage form with aspirin and fumaric acid
A dosage form comprising an effective amount of aspirin and an effective amount of fumaric acid or an ester or a salt thereof, wherein the aspirin and fumaric acid or an ester or a salt thereof are each individually formulated as enterically coated microspheres.
Capsule with individually enterically coated microspheres of aspirin and fumaric acid
A capsule comprising a dosage form comprising an effective amount of aspirin and an effective amount of fumaric acid or an ester or a salt thereof, wherein the aspirin and fumaric acid or an ester or a salt thereof are each individually formulated as enterically coated microspheres contained within the capsule shell.
Together, the independent claims define co-formulated aspirin and fumaric acid/ester/salt delivery in which both components are separately formulated as enterically coated microspheres, either as a dosage form or as a capsule containing those individually enterically coated microsphere components in the capsule shell.
Stated Advantages
Aspirin co-administration increases fumarate bioavailability.
Aspirin co-administration reduces dimethyl fumarate-associated flushing severity.
The document describes enabling lower effective fumarate daily doses while addressing flushing severity.
Documented Applications
Oral treatment regimens for multiple sclerosis using concomitant aspirin and fumaric acid/fumarate.
Treatment contexts described include relapse-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS).
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