Use of (1S,3S)-3-amino-4-(difluoromethylidene) cyclopentane-1-carboxylic acid and (S)-3-amino-4-(difluoromethylenyl)cyclopent-1-ene-1-carboxylic acid in the treatment of tinnitus, acute sensorineural hearing loss, Meniere's disease, Tourette's syndrome, attention deficit hyperactivity disorder and addiction
Inventors
Assignees
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Publication Number
US-11771671-B2
Publication Date
2023-10-03
Expiration Date
Abstract
Methods of treating tinnitus, acute sensorineural hearing loss, Meniere's disease, Tourette's syndrome, ADHD or addiction with (1S,3S)-3-amino-4-(difluoromethylidene) cyclopentane-1-carboxylic acid or a pharmaceutically acceptable salt thereof are provided. Methods of treating tinnitus, acute sensorineural hearing loss, Meniere's disease, Tourette's syndrome, ADHD or addiction with (S)-3-amino-4-(difluoromethylenyl)cyclopent-1-ene-1-carboxylic acid are provided. Also provided are therapeutic compositions that may be used to improve one or more symptoms of tinnitus, acute sensorineural hearing loss, Meniere's disease, Tourette's syndrome, ADHD or addiction.
Core Innovation
The patent describes therapeutic methods for treating tinnitus and related auditory symptoms using difluorinated cyclopentane carboxylic acid stereoisomers, specifically (1S,3S)-3-amino-4-(difluoromethylidene)cyclopentane-1-carboxylic acid and (S)-3-amino-4-(difluoromethylenyl)cyclopent-1-ene-1-carboxylic acid, including pharmaceutically acceptable salts and combinations. The document frames the invention around treating conditions involving hearing and ear-related sensations.
The methods include alleviating aural fullness or hearing loss in one or both ears associated with sudden sensorineural hearing loss, with subject selection that excludes subjects who have tinnitus. Administration is defined as providing an amount within specified ranges for each stereoisomer, and alleviating the aural fullness or hearing loss is identified as the therapeutic outcome.
The patent further characterizes the invention by specifying administration patterns and delivery options, including dosing frequency and selected routes of administration. The document also states that the stereoisomers may be used in combination or co-therapy with other medicinal products, and it includes pharmacokinetic information and exposure targets to support the treatment concept.
Claims Coverage
The provided claim set includes two independent claims, each focused on treating aural fullness or hearing loss in one or both ears associated with sudden sensorineural hearing loss by administering a specified stereoisomer or pharmaceutically acceptable salt to subjects who do not have tinnitus. Across both independent claims, the inventive features differ by the stereoisomer selected and the claimed dosage range.
Treating aural fullness or hearing loss without tinnitus using (1S,3S) difluoromethylidene cyclopentane carboxylic acid
Administering to a patient who does not have tinnitus (1S,3S)-3-amino-4-(difluoromethylidene)cyclopentane-1-carboxylic acid or a pharmaceutically acceptable salt thereof in an amount of from 0.01 mg to 500 mg and alleviating the aural fullness or hearing loss in the patient for sudden sensorineural hearing loss.
Treating aural fullness or hearing loss without tinnitus using (S) difluoromethylenyl cyclopent-1-ene carboxylic acid
Administering to a subject who does not have tinnitus (S)-3-amino-4-(difluoromethylenyl)cyclopent-1-ene-1-carboxylic acid or a pharmaceutically acceptable salt thereof in an amount of from 0.01 mg to 75 mg and alleviating the aural fullness or hearing loss in the subject for sudden sensorineural hearing loss.
Both independent claims cover therapeutic treatment of aural fullness or hearing loss associated with sudden sensorineural hearing loss in subjects who do not have tinnitus, using either (1S,3S)-3-amino-4-(difluoromethylidene)cyclopentane-1-carboxylic acid or (S)-3-amino-4-(difluoromethylenyl)cyclopent-1-ene-1-carboxylic acid, with specified administration amount ranges and the therapeutic outcome of alleviation.
Stated Advantages
Alleviation of aural fullness or hearing loss in one or both ears associated with sudden sensorineural hearing loss.
Improvement is described in time-based terms following administration, including more than 6 hours and extended improvement durations described in the document.
Combination therapy is asserted to provide synergistic and more-than-additive effects for symptom improvement.
Next-day improvement of symptoms.
Documented Applications
Treating tinnitus and achieving efficacy/safety across dosing schedules in a study example outline, including schedules with clobazam.
Treating aural fullness or hearing loss associated with sudden sensorineural hearing loss in patients or subjects who do not have tinnitus.
Treating tinnitus, acute sensorineural hearing loss (ASNHL/SSNHL), Meniere’s disease, Tourette’s syndrome, ADHD, and addiction.
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