US 11,903,940 B2
Methods of treating disease with levoketoconazole
Fredric Cohen, Washington Crossing, PA (US)
Assigned to Strongbridge Dublin Limited, Trevose, PA (US)
Filed by Strongbridge Dublin Limited, Trevose, PA (US)
Filed on Mar. 21, 2022, as Appl. No. 17/655,632.
Application 17/655,632 is a continuation of application No. 17/319,781, filed on May 13, 2021, granted, now 11,278,547.
Application 17/319,781 is a continuation of application No. 17/010,387, filed on Sep. 2, 2020, granted, now 11,020,393, issued on Jun. 1, 2021.
Application 17/010,387 is a continuation of application No. PCT/US2020/020644, filed on Mar. 2, 2020.
Claims priority of provisional application 62/813,399, filed on Mar. 4, 2019.
Prior Publication US 2022/0387425 A1, Dec. 8, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/497 (2006.01); A61K 31/155 (2006.01)
CPC A61K 31/497 (2013.01) [A61K 31/155 (2013.01)] 18 Claims
 
1. A method of treating persistent or recurrent Cushing's syndrome in a subject in need thereof, wherein the subject is being coadministered an organic cation transporter 2 (OCT2) substrate, or a pharmaceutically acceptable salt thereof, comprising:
administering a therapeutically effective amount of levoketoconazole, or a pharmaceutically acceptable salt thereof, to the subject in need thereof, wherein the therapeutically effective amount of levoketoconazole, or a pharmaceutically acceptable salt thereof, is determined via a titration scheme;
during the levoketoconazole titration scheme, monitoring the subject for a dose limiting event, wherein the dose limiting event is due to increased exposure to the OCT2 substrate; and
if the subject experiences a dose limiting event, reducing the amount of the OCT2 substrate, or a pharmaceutically acceptable salt thereof, administered to the subject.