US 12,440,457 B2
Methods of treating suicidality
Raj Mehra, New York, NY (US); and Timothy Whitaker, New York, NY (US)
Assigned to Seelos Therapeutics, Inc., New York, NY (US)
Filed by Seelos Therapeutics, Inc., New York, NY (US)
Filed on Apr. 11, 2023, as Appl. No. 18/133,176.
Application 18/133,176 is a continuation of application No. 17/792,208, previously published as PCT/US2021/014748, filed on Jan. 22, 2021.
Claims priority of provisional application 63/079,791, filed on Sep. 17, 2020.
Claims priority of provisional application 62/964,598, filed on Jan. 22, 2020.
Prior Publication US 2023/0241008 A1, Aug. 3, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/135 (2006.01); A61K 9/00 (2006.01); A61K 45/06 (2006.01); A61P 25/24 (2006.01)
CPC A61K 31/135 (2013.01) [A61K 9/0043 (2013.01); A61K 45/06 (2013.01); A61P 25/24 (2018.01); A61K 2300/00 (2013.01)] 26 Claims
OG exemplary drawing
 
1. A method for reducing suicidality in a subject in need thereof, comprising:
(a) identifying the subject as having a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from 35-60 units; and
(b) intranasally administering to the subject about 30 mg to about 90 mg of racemic ketamine, or a pharmaceutically acceptable salt thereof, once every 3 to 4 days for 15 days, wherein ketamine is the sole therapeutic agent administered during the 15 days,
wherein intranasal administration of the racemic ketamine, or a pharmaceutically acceptable salt thereof, exhibits one or more of:
an AUC0-24 of norketamine at day 1, 4, or 8 after the intranasal administration that is at least 1.5 times higher than the AUC0-24 of norketamine exhibited by intravenous administration of an equivalent dose of racemic ketamine at day 1, 4, or 8 after the intravenous administration;
an AUC0-inf of norketamine at day 1, 4, or 8 after the intranasal administration that is at least 1.5 times higher than the AUC0-inf of norketamine exhibited by intravenous administration of an equivalent dose of racemic ketamine at day 1, 4, or 8 after the intravenous administration;
a Cmax of norketamine at day 1, 4, or 8 after the intranasal administration that is at least 2 times higher than the Cmax of norketamine exhibited by intravenous administration of an equivalent dose of racemic ketamine at day 1, 4, or 8 after the intravenous administration;
thereby reducing suicidality in the subject compared to suicidality in the subject prior to the administering of racemic ketamine, or a pharmaceutically acceptable salt thereof.