	US 12,280,037 B2
	Method and pharmaceutical composition for treating or preventing trichomoniasis and uses thereof
Helen S. Pentikis, Baltimore, MD (US); David Palling, Philadelphia, PA (US); Carol J. Braun, Baltimore, MD (US); Richard Holl, Rolla, MO (US); and Gregory Kaufman, Short Hills, NJ (US)
Assigned to EVOFEM BIOSCIENCES, INC., San Diego, CA (US)
Filed by EVOFEM BIOSCIENCES, INC., San Diego, CA (US)
Filed on Sep. 22, 2020, as Appl. No. 17/028,838.
Prior Publication US 2022/0087978 A1, Mar. 24, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/4164 (2006.01); A61K 9/00 (2006.01); A61K 9/16 (2006.01); A61K 31/566 (2006.01); A61K 31/567 (2006.01); A61K 31/69 (2006.01); A61K 31/702 (2006.01); A61P 33/02 (2006.01)

CPC A61K 31/4164 (2013.01) [A61K 9/0056 (2013.01); A61K 9/16 (2013.01); A61K 31/566 (2013.01); A61K 31/567 (2013.01); A61K 31/69 (2013.01); A61K 31/702 (2013.01); A61P 33/02 (2018.01)]

29 Claims

1. A method of treating trichomoniasis in a human in need thereof comprising orally administering to the human a microgranule formulation comprising a therapeutically effective amount of secnidazole or a pharmaceutically acceptable salt thereof that exhibits a maximum plasma concentration (Cmax) of 29.15 μg/ml to 31.05 μg/ml and a time to maximum plasma concentration (T_max) of 6.6 hours to 24 hours in the human, wherein the microgranule formulation comprises a plurality of microgranules, each microgranule comprises secnidazole and has a particle diameter in the range of 400 micrometers to 841 micrometers, wherein secnidazole or the pharmaceutically acceptable salt thereof is the sole drug in the microgranule formulation.