US 12,280,022 B2
Method of treating major depressive disorder
Elena Kagan, Rehovot (IL); and Gina Pastino, Media, PA (US)
Assigned to CLEXIO BIOSCIENCES LTD., Yokne'am (IL)
Filed by Clexio Biosciences Ltd., Jerusalem (IL)
Filed on Nov. 8, 2023, as Appl. No. 18/504,388.
Application 18/504,388 is a continuation of application No. 18/193,122, filed on Mar. 30, 2023, granted, now 11,957,645.
Application 18/193,122 is a continuation of application No. 17/571,731, filed on Jan. 10, 2022, granted, now 12,016,832.
Application 17/571,731 is a continuation of application No. 17/229,623, filed on Apr. 13, 2021, granted, now 11,253,487, issued on Feb. 22, 2022.
Application 17/229,623 is a continuation of application No. 16/592,930, filed on Oct. 4, 2019, granted, now 11,865,088.
Claims priority of provisional application 62/867,354, filed on Jun. 27, 2019.
Claims priority of provisional application 62/741,562, filed on Oct. 5, 2018.
Claims priority of application No. PCT/IB2018/059107 (WO), filed on Nov. 19, 2018.
Prior Publication US 2024/0074991 A1, Mar. 7, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/135 (2006.01); A61K 9/00 (2006.01); A61K 9/16 (2006.01); A61K 31/136 (2006.01); A61K 31/15 (2006.01); A61K 31/343 (2006.01); A61K 31/36 (2006.01); A61K 31/381 (2006.01); A61K 31/7034 (2006.01); A61P 25/24 (2006.01)
CPC A61K 31/135 (2013.01) [A61K 9/0053 (2013.01); A61K 9/1611 (2013.01); A61K 9/1623 (2013.01); A61K 9/1635 (2013.01); A61K 9/1652 (2013.01); A61K 9/167 (2013.01); A61K 31/136 (2013.01); A61K 31/15 (2013.01); A61K 31/343 (2013.01); A61K 31/36 (2013.01); A61K 31/381 (2013.01); A61K 31/7034 (2013.01); A61P 25/24 (2018.01)] 20 Claims
 
1. A method of treating major depressive disorder (MDD) in a human patient in need thereof consisting essentially of orally administering once daily to said patient for at least 28 days an oral dosage form comprising esketamine, wherein
a) the esketamine Cmax of said administration is between 5 ng/ml and 30 ng/mL, or
b) the esketamine AUC0-t of said administration is between 15 ng*h/ml and 60 ng*h/ml, or
c) the esketamine Cmax of said administration is between 5 ng/mL and 30 ng/mL and the esketamine AUC0-t of said administration is between 15 ng*h/ml and 60 ng*h/ml; and
optionally, further comprising administering an antidepressant, an antimanic agent or an anxiolytic drug.