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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-10398712-B2
Publication Date
2019-09-03
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
The document discloses treating multiple sclerosis, including relapse-remitting MS (RRMS) and secondary progressive MS (SPMS), by orally administering aspirin together with fumaric acid or an ester or salt thereof. The disclosed combinations include dimethyl fumarate and related fumarate esters/salts such as monomethyl fumarate, with specified daily dose ranges for aspirin and dimethyl fumarate.
A co-formulation concept is described in which aspirin is delivered via an oral dissolvable or intraoral portion, including an intraoral portion that dissolves in an oral cavity and/or via buccal absorption. In parallel, the fumarate is delivered via a gastrointestinal tract dissolving or swallowable portion, allowing distinct portions within an oral dosage form such as tablets or capsules, and may include enteric-coated microspheres.
The document highlights aims related to flushing and gastrointestinal tolerability, including DMF-associated flushing and gastrointestinal side effects. It reports reduced flushing severity based on a Global Flushing Severity Scale (GFSS) and pharmacokinetic outcomes, including an observed increase in DMF bioavailability (AUC) with aspirin co-administration and shifts in pharmacokinetic parameters such as T_max.
Claims Coverage
The included claim content presents one independent claim directed to a method of treating multiple sclerosis with an aspirin and dimethyl fumarate oral dosage form having specified daily ranges, with at least part of the aspirin dissolving in the oral cavity. Dependent claims refine the dimethyl fumarate dissolution location, dosage form, and dose range.
Oral aspirin with dimethyl fumarate treating multiple sclerosis with oral cavity dissolution
Orally administering a dosage form comprising aspirin and dimethyl fumarate to treat multiple sclerosis in a human patient in need thereof, with aspirin administered at from about 150 mg to about 650 mg per day and dimethyl fumarate administered at from 300 mg to 450 mg per day, wherein at least a portion of the aspirin is formulated to dissolve in an oral cavity of a subject.
Gastrointestinal dissolution of dimethyl fumarate portion
Formulating the dimethyl fumarate to dissolve in the stomach, intestines, or further distal in the gastrointestinal tract of the subject.
Capsule dosage form
Providing the pharmaceutical composition in the form of a capsule.
Specific dimethyl fumarate daily dose range
Administering dimethyl fumarate at a daily dose ranging from 350 mg to 430 mg per day.
The claim coverage centers on oral co-administration of aspirin and dimethyl fumarate for treating multiple sclerosis with specified daily ranges and at least partial oral cavity dissolution of aspirin. Dependent limitations further specify gastrointestinal dissolution of dimethyl fumarate, a capsule dosage form, and a narrower dimethyl fumarate dose range.
Stated Advantages
Reduced flushing severity, including DMF-associated flushing, as assessed using a Global Flushing Severity Scale (GFSS).
Improved DMF bioavailability, including an observed approximately 5% increase in DMF bioavailability (AUC) with aspirin co-administration.
Improved pharmacokinetic and related tolerability outcomes, including shifts in T_max and associated tolerability outcomes.
Documented Applications
Treating multiple sclerosis in a human patient in need thereof, including relapse-remitting MS (RRMS) and secondary progressive MS (SPMS).
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