AU2022200892A1 — Use of sublingual Dexmedetomidine for the treatment of agitation

USPTO 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. Cumulative duration of aggressive and agItated behaviors 10W 75 . 1~F-1 Anagenital Sniffing Chasing Attack Biting lilNC |||whnideE DeO; '.5g/kg; SL Dex;1g/kg; L ! Dex; Lpg/kg; St Dx 3pg;St a Dri a; 3mg/kg p Figure A. FetTct of'sublinguallyadninisteredDexnedetoridinehydrochloride(Dex)at varying doses (0.5- 3 pg/kg) on cumulative duration of aggressive and agitated behaviors. Data expressed as Mean SEM. One-way ANOVA followed by Dunnett's pot-oc test. *p<0.05 **p<0.01, ***p<O.0 and ****p<O,OOI vs vehicle controls (vehicle).