Use of sublingual dexmedetomidine for the treatment of agitation
Inventors
Nandabalan, Krishnan • Yocca, Frank • Sharma, Sameer • NEGI, Harsh • Saini, Deepa
Assignees
E Z Bioxcel Solutions Pvt Ltd • Bioxcel Therapeutics Inc • Bioxcel LLC
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Publication Number
US-11931340-B2
Publication Date
2024-03-19
Expiration Date
Abstract
The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
Core Innovation
The invention relates to a method of treating agitation in an agitated subject having Alzheimer's Disease by administering dexmedetomidine or a pharmaceutically acceptable salt thereof to the oral mucosa. The administration is provided as one or two single dosage administrations and produces an anti-agitation effect in less than about 60 minutes after administration without also causing significant sedation.
The dexmedetomidine or pharmaceutically acceptable salt is administered in a solid, water-soluble dosage form. The disclosed implementations include a film, a wafer, and a tablet, and the oral mucosa administration includes sublingual and buccal delivery. Additional disclosed variants include administering dexmedetomidine hydrochloride.
Claims Coverage
The provided claim set contains two independent claims. Both independent claims focus on rapid anti-agitation effect after oral mucosa administration of dexmedetomidine or a pharmaceutically acceptable salt without significant sedation, with additional limitations on non-perioperative agitation and dosage/form.
Oral mucosa anti-agitation dosing without significant sedation
Administering to the oral mucosa of an agitated subject one or two single dosage administrations of dexmedetomidine or a pharmaceutically acceptable salt thereof without also causing significant sedation after the administration, wherein the effective amount produces an anti-agitation effect in less than about 60 minutes after administration.
Solid, water-soluble oral-mucosa dosage form
Administering the dexmedetomidine or a pharmaceutically acceptable salt thereof in a solid, water-soluble dosage form.
Non-perioperative agitation treatment context
Treating agitation that is not perioperative agitation.
Fixed single dosage amount of 60 micrograms
Administering each of the one or two single dosages of dexmedetomidine or a pharmaceutically acceptable salt thereof at a dosage of 60 micrograms.
Film dosage form limitation
Administering the dexmedetomidine or a pharmaceutically acceptable salt thereof as a film.
Across the two independent claims, the core coverage is limited to treating agitation in an Alzheimer's Disease subject by administering dexmedetomidine or a pharmaceutically acceptable salt to the oral mucosa to achieve an anti-agitation effect in less than about 60 minutes without significant sedation, using a solid water-soluble dosage form with a specified fixed dosage amount, and in one independent claim specifically requiring a film.
Stated Advantages
Produces an anti-agitation effect in less than about 60 minutes after administration.
Does not also cause significant sedation after the administration.
Documented Applications
Treating agitation signs in an agitated subject having Alzheimer's Disease.
Using an in vivo rat resident-intruder model to evaluate sublingual versus intravenous dosing effects on aggressive/agitated behavioral indices and plasma concentrations.
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