	US 12,076,300 B2
	Dosage regime with esketamine for treating major depressive disorder
Johanna Schumann, Jerusalem (IL); and Dorit Mimrod, Jerusalem (IL)
Assigned to CLEXIO BIOSCIENCES LTD., Petach Tikva (IL)
Filed by CLEXIO BIOSCIENCES LTD., Jerusalem (IL)
Filed on Mar. 30, 2023, as Appl. No. 18/193,083.
Application 18/193,083 is a continuation of application No. 17/789,631, previously published as PCT/IB2020/062507, filed on Dec. 29, 2020.
Claims priority of provisional application 62/954,779, filed on Dec. 30, 2019.
Prior Publication US 2023/0248666 A1, Aug. 10, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/135 (2006.01); A61K 31/137 (2006.01); A61K 31/138 (2006.01); A61K 31/15 (2006.01); A61K 31/343 (2006.01); A61K 31/381 (2006.01); A61K 31/4525 (2006.01); A61K 45/06 (2006.01); A61P 25/24 (2006.01)

CPC A61K 31/135 (2013.01) [A61K 31/137 (2013.01); A61K 31/138 (2013.01); A61K 31/15 (2013.01); A61K 31/343 (2013.01); A61K 31/381 (2013.01); A61K 31/4525 (2013.01); A61K 45/06 (2013.01); A61P 25/24 (2018.01)]

5 Claims

1. A method of improving the Montgomery-Åsberg Depression Rating Scale (MADRS) score of a human patient suffering from major depressive disorder (MDD) and in need of treatment thereof, at at least day 28 of a treatment regimen, when compared to placebo comprising:

orally administering to said patient, once daily, at night, before the patient goes to sleep,

a dosage form comprising 60 mg of immediate-release esketamine, or a pharmaceutically acceptable salt thereof, over the treatment regimen;

wherein, more than 8 hours after the administration, the oral administration of the dosage form does not result in a mental or motor impairment that negatively affects the patient's ability to operative a motor vehicle.