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AssigneeLupin Limited
InventorsHelen S. PENTIKIS, David PALLING, Carol J. BRAUN, Richard HOLL, Gregory KAUFMAN
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Method of treating or preventing trichomoniasis or T. vaginalis infection in a subject in need thereof, the method involving administering to the subject a therapeutically effective amount of secnidazole or a pharmaceutically acceptable salt in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules. The subject can also have bacterial vaginosis, is HIV-positive, and/or is suffering with metronidazole-resistant trichomoniasis and/or tinidazole-resistant trichomoniasis. The subject can also be a sexual partner of a person with trichomoniasis. The microgranule formulation can also be administered with paromomycin, tinidazole, metronidazole, boric acid or a combination thereof. Pharmaceutical compositions and uses for treating or preventing trichomoniasis or T. vaginalis infection in a subject in need thereof are also contemplated herein.
A method of treating trichomoniasis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of secnidazole or a pharmaceutically acceptable salt thereof in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules, wherein the therapeutically effective amount of secnidazole or the pharmaceutically acceptable salt thereof is an amount of secnidazole or the pharmaceutically acceptable salt thereof that exhibits a maximum plasma concentration (Cmax) of about 26 μg/ml to about 34 μg/ml in the subject, and wherein secnidazole or the pharmaceutically acceptable salt thereof is the sole drug in the microgranule formulation.
A method of treating trichomoniasis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of secnidazole or a pharmaceutically acceptable salt thereof in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules, wherein the therapeutically effective amount of secnidazole or the pharmaceutically acceptable salt thereof is an amount of secnidazole or the pharmaceutically acceptable salt thereof that exhibits a time to maximum plasma concentration (Tmax) of about 6 hours to about 24 hours in the subject, and wherein secnidazole or the pharmaceutically acceptable salt thereof is the sole drug in the microgranule formulation.
A method of treating trichomoniasis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of secnidazole or a pharmaceutically acceptable salt thereof in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules, wherein secnidazole or the pharmaceutically acceptable salt thereof is the sole drug in the microgranule formulation, wherein the subject also has bacterial vaginosis and/or is HIV-positive, and wherein the microgranule formulation has a microbiological cure rate of at least 95% or 100%.
A method of treating trichomoniasis in a subject in need thereof comprising administering to the subject a total daily dose of 2 grams, 4 grams or 6 grams of secnidazole or a pharmaceutically acceptable salt thereof in a microgranule formulation for a period of 1 day to 14 days, wherein the microgranule formulation comprises a plurality of microgranules, and wherein secnidazole or the pharmaceutically acceptable salt thereof is the sole drug in the microgranule formulation.
A method of treating trichomoniasis in a subject who is a sexual partner to a person with trichomoniasis, the method comprising administering to the subject a total daily dose of 2 grams, 4 grams or 6 grams of secnidazole or a pharmaceutically acceptable salt thereof in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules, and wherein secnidazole or the pharmaceutically acceptable salt thereof is the sole drug in the microgranule formulation.
A method of treating trichomoniasis in subjects in need thereof, the method comprising the steps of:
The method of claim 41, wherein the rate of primary endpoint of microbiological cure at step (c) for the mITT population is at least 0.5%, at least 10%, at least 50%, at least 90%, or 100%.
Dependencies are inferred from the claim text.