US 12,336,970 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. 22, 2023, as Appl. No. 18/517,062.
Application 18/517,062 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 2024/0091174 A1, Mar. 21, 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)] 16 Claims
 
1. A method of treating major depressive disorder (MDD) in a human patient in need thereof consisting essentially of
orally administering to said patient an oral dosage form consisting of esketamine and a pharmaceutical carrier over a treatment regimen of at least 28 days, wherein the ratio of S-norketamine Cmax to esketamine Cmax after the administration of the esketamine is at least 6;
and optionally administering to said patient a second medication that is an antidepressant, an antimanic agent, or an anxiolytic drug that does not alter the metabolism of the esketamine in the patient, wherein the ratio of S-norketamine Cmax to esketamine Cmax after the coadministration of the esketamine and the second medication is at least 6.