A19-144, A2-73 and certain anticholinesterase inhibitor compositions and method for anti-seizure therapy
Inventors
Missling, Christopher U. • DURRANT, Cameron
Assignees
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Publication Number
US-11690821-B2
Publication Date
2023-07-04
Expiration Date
Abstract
This invention concerns a dosage form comprising a therapeutically effective amount of A19-144 or A2-73 and a therapeutically effective amount of at least one AED. This invention further encompasses a method of treating a subject in need of such treatment comprising administering a therapeutically effective amount of A19-144 or A2-73 in conjunction with any therapeutically effective amount of an AED.
Core Innovation
The invention relates to an anti-seizure dosage form and anti-seizure therapy that uses an active selected from tetrahydro-N-methyl-2,2-diphenyl-3-furanomethanamine or tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanomethanamine, or a combination thereof, including pharmaceutically acceptable salts. The therapeutically effective amount is defined as an amount that elicits a pharmacological response of reduction in the daily number of seizures by at least 50%.
The invention further emphasizes using the active in combination with at least one anti-epilepsy drug (AED). The disclosed approach includes administering a sub-MED amount of the AED together with the active, aiming to achieve seizure reduction while addressing memory impairment.
The document describes co-timely or coordinated administration of the active and the AED, including maintaining coordinated plasma levels, and includes prophylaxis-focused outcomes. The disclosure also refers to receptor activity of A19-144/A2-73 and preclinical discussion of amyloid/Tau-related effects and pathway-related mechanisms.
Claims Coverage
The provided claim set covers one independent dosage-form claim with the specified active structures and a seizure-reduction threshold, with dependent refinements adding sub-MED AED co-administration and administration/tolerability conditions. The main inventive coverage is the defined active(s) and the therapeutically effective amount that elicits at least a 50% reduction in the daily number of seizures.
Seizure-reduction dosage form defined by tetrahydro-furanomethanamine active(s)
A dosage form comprising a therapeutically effective amount of tetrahydro-N-methyl-2,2-diphenyl-3-furanomethanamine or tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanomethanamine, or pharmaceutically acceptable salts, or a combination, wherein the therapeutically effective amount elicits a pharmacological response of reduction in the daily number of seizures by at least 50%.
Sub-MED AED combination in the dosage form
The dosage form further includes a sub-med amount of at least one anti-epilepsy drug (AED) together with the active.
Sub-MED AED selection with less-than quantitative thresholds
The sub-med amount of at least one AED is selected as one or more drugs at sub-MED doses limited to the listed less than quantitative thresholds, including their combinations.
Co-timely administration of the AED with the active
A method requires administering the at least one AED co-timely with administering the active.
Memory tolerability condition after AED administration
The method includes an AED administration condition in which the subject does not show a decrease in memory after AED administration compared with before AED administration.
Across the provided claim information, the inventive core is a dosage form defined by tetrahydro-N-methyl-2,2-diphenyl-3-furanomethanamine or tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanomethanamine, or salts or combination, administered in a therapeutically effective amount that elicits at least a 50% reduction in the daily number of seizures. The coverage is further refined by adding a sub-MED amount of at least one AED selected using less than quantitative thresholds, and by requiring co-timely administration and a memory tolerability condition.
Stated Advantages
Reduction in the daily number of seizures by at least 50%.
Reduced memory impairment associated with the sub-MED AED combination approach.
Documented Applications
Seizure prophylaxis in specific subjects, including co-timed dosing with donepezil, where no detected seizures were reported and memory was described as preserved.
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