Secnidazole for use in the treatment of sexually transmitted infection

A method of treating a sexually transmitted infection (STI) in a subject in need thereof, the method comprising:

• administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules, each microgranule comprises a sugar core or a microcrystalline cellulose core, and an outer layer on the sugar core or the microcrystalline cellulose core, the outer layer comprises secnidazole,
• wherein at least 10% of the plurality of microgranules have a volume-weighted particle diameter equal to or larger than 470 micrometers as measured by laser diffraction,
• wherein the microgranule formulation provides a time to maximum plasma concentration (Tmax) of secnidazole of about 2 hours to about 6 hours after administering to the subject), and wherein the secnidazole is the sole drug in the microgranule formulation.

A method of treating trichomoniasis in a subject in need thereof, the method comprising:

• administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules, each microgranule comprises a sugar core or a microcrystalline cellulose core, and an outer layer on the sugar core or the microcrystalline cellulose core, the outer layer comprises secnidazole,
• wherein at least 10% of the plurality of microgranules have a volume-weighted particle diameter equal to or larger than 470 micrometers as measured by laser diffraction, wherein the microgranule formulation provides a maximum plasma concentration (Cmax) of secnidazole in the subject of about 34.5 μg/ml to about 58.3 μg/ml or a time to maximum plasma concentration (Tmax) of secnidazole of about 2 hours to about 6 hours after administering to the subject, and wherein the secnidazole is the sole drug in the microgranule formulation.

A pharmaceutical composition comprising a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules, each microgranule comprises a sugar core or a microcrystalline cellulose core, and an outer layer on the sugar core or the microcrystalline cellulose core, the outer layer comprises secnidazole,

• wherein at least 10% of the plurality of microgranules have a volume-weighted particle diameter equal to or larger than 470 micrometers as measured by laser diffraction, wherein the microgranule formulation provides a maximum plasma concentration (Cmax) of secnidazole in the subject of about 34.5 μg/ml to about 58.3 μg/ml or a time to maximum plasma concentration (Tmax) of secnidazole of about 2 hours to about 6 hours after administering to the subject, and wherein the secnidazole is the sole drug in the microgranule formulation.