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US 2026/0083705 A1Published application
Transdermal dexmedetomidine for treating agitation
AssigneeTeikoku Pharma USA, Inc.
InventorsWan-Ning Song, Gary G. Kay
Life of this patent
Estimating the term…
Abstract
The present disclosure relates to methods of using transdermal delivery patches containing dexmedetomidine to treat agitation.
Claims31
A method of treating agitation in a subject in need thereof, comprising applying one or more transdermal delivery patches to a skin surface of the subject, who is not agitated at the time of application, wherein:
- each transdermal delivery patch comprises a pharmaceutical composition comprising dexmedetomidine;
- the one or more transdermal delivery patches deliver a therapeutically effective non-sedating amount of dexmedetomidine to the subject;
- each transdermal delivery patch comprises a drug layer affixed to a backing layer, wherein the drug layer comprises from 1 mg to 3.5 mg dexmedetomidine, a pressure sensitive adhesive comprising a hydroxyl functionalized acrylate polymer, and lauryl lactate;
- wherein:
- the drug layer has an adhesive surface suitable for adhesion to a skin surface, wherein the adhesive surface has a surface area from 3 cm2 to 20 cm2;
- and
- the backing layer comprises polyethylene and polyethylene terephthalate;
- the subject has an Agitated Behavior Scale (ABS) score of at least 22 at least once when assessed on one of the four days prior to application of the one or more transdermal delivery patches;
- and
- the subject's ABS score 96 hours following application and maintenance of the one or more transdermal delivery patches on the skin surface of the subject is reduced compared to the subject's baseline ABS score assessed prior to application of the one or more transdermal delivery patches.
7 more elements
2-81. (canceled)
A method of treating agitation in a subject in need thereof, comprising applying one or more transdermal delivery patches to a skin surface of the subject, who is not agitated at the time of application, wherein:
- each transdermal delivery patch comprises a pharmaceutical composition comprising dexmedetomidine;
- the one or more transdermal delivery patches deliver a therapeutically effective non-sedating amount of dexmedetomidine to the subject;
- each transdermal delivery patch comprises a drug layer affixed to a backing layer, wherein the drug layer comprises from 1 mg to 3.5 mg dexmedetomidine, a pressure sensitive adhesive comprising a hydroxyl functionalized acrylate polymer, and lauryl lactate;
- wherein:
- the drug layer has an adhesive surface suitable for adhesion to a skin surface, wherein the adhesive surface has a surface area from 3 cm2 to 20 cm2;
- and
- the backing layer comprises polyethylene and polyethylene terephthalate;
- the subject has a diagnosis of dementia of probable Alzheimer's Disease;
- and
- the subject's ABS score 96 hours following application and maintenance of the one or more transdermal delivery patches on the skin surface of the subject is reduced compared to the subject's baseline ABS score assessed prior to application of the one or more transdermal delivery patches.
7 more elements
Dependencies are inferred from the claim text.