Betahistine, or a pharmaceutically acceptable salt thereof, and a monoamine oxidase inhibitor, for use in the treatment or prevention of one or more symptoms of vertigo in a subject
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Publication Number
US-12121513-B2
Publication Date
2024-10-22
Expiration Date
Abstract
A first aspect of the invention relates to betahistine, or a pharmaceutically acceptable salt thereof, and a monoamine oxidase inhibitor, for use in the treatment or prevention of one or more symptoms of vertigo in a subject.A second aspect of the invention relates to a method of treating or preventing one or more symptoms of vertigo in a subject, said method comprising administering to the subject (i) betahistine, or a pharmaceutically acceptable salt thereof, and (ii) a monoamine oxidase inhibitor.
Core Innovation
The invention relates to combination therapy for treating or preventing one or more symptoms of vertigo in a subject. The method administers an effective amount of a combination including betahistine, or a pharmaceutically acceptable salt thereof, together with a monoamine oxidase (MAO) inhibitor, or a pharmaceutically acceptable salt thereof. The claimed approach targets vertigo symptoms using a defined two-active-agent combination rather than betahistine alone.
A problem addressed in the background is that betahistine monotherapy evidence for vertigo is inconsistent, and there is a need for improved outcomes in treating vertigo symptoms. The disclosed rationale is based on the known actions of betahistine and the use of MAO inhibitors, including MAO-A inhibitors and MAO-B inhibitors. The document further indicates that the combination is expected to provide enhanced efficacy and to avoid antagonistic interaction.
The described subject matter includes specific MAO inhibitors for use in the combination, including isocarboxazid, nialamide, phenelzine, hydracarbazine, tranylcypromine, benmoxin, iproclozide, iproniazid, mebanazine, octamoxin, pheniprazine, phenoxypropazine, pivalylbenhydrazine, safrazine, caroxazone, bifemelane, moclobemide, pirlindole, toloxatone, and minaprine, each as free base or pharmaceutically acceptable salts. Vertigo indications discussed include peripheral vertigo and Menière’s disease, including conditions such as vestibular neuritis, benign paroxysmal positional vertigo (BPPV), labyrinthitis, and other peripheral etiologies, with administration that can be simultaneous or sequential or separate.
Claims Coverage
The document includes one independent claim defining a vertigo treatment/prevention method, where the combination is characterized by betahistine plus an MAO inhibitor selected from a specified list. Across the claim family, dependent claims refine the MAO inhibitor selection by specifying particular MAO inhibitors, with optional pharmaceutically acceptable salt forms.
Betahistine plus monoamine oxidase inhibitor combination for vertigo symptoms
A method of treating or preventing one or more symptoms of vertigo in a subject by administering an effective amount of a combination comprising betahistine, or a pharmaceutically acceptable salt thereof, and a monoamine oxidase (MAO) inhibitor, or a pharmaceutically acceptable salt thereof, wherein the MAO inhibitor is selected from isocarboxazid, nialamide, phenelzine, hydracarbazine, tranylcypromine, benmoxin, iproclozide, iproniazid, mebanazine, octamoxin, pheniprazine, phenoxypropazine, pivalylbenhydrazine, safrazine, caroxazone, bifemelane, moclobemide, pirlindole, toloxatone, minaprine, or pharmaceutically acceptable salts of those MAO inhibitors.
The claim coverage centers on combining betahistine with a specified MAO inhibitor, or its pharmaceutically acceptable salt, to treat or prevent one or more symptoms of vertigo, with dependent claims refining the MAO inhibitor identity within the enumerated set.
Stated Advantages
Improved outcomes with unexpectedly enhanced efficacy compared with monotherapy is described.
Reduced betahistine dose requirements are described.
Absence of adverse antagonistic interaction is described.
Documented Applications
Treating or preventing symptoms of vertigo, including peripheral vertigo and Menière’s disease, is described.
Managing vertigo associated with peripheral etiologies such as vestibular neuritis, benign paroxysmal positional vertigo (BPPV), labyrinthitis, and other peripheral etiologies is described.
An observational study in 13 Menière’s patients is described, including maintaining a target attack frequency while reducing betahistine dose.
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