Claims for Patent: 10,335,390

Summary for Patent: 10,335,390

Title:	Secnidazole for use in the treatment of bacterial vaginosis
Abstract:	Embodiments are directed to a secnidazole formulations and the use of a secnidazole formulation for the treatment of bacterial vaginosis (BV).
Inventor(s):	Helen S. PENTIKIS, David Palling, Carol J. BRAUN
Assignee:	Evofem Biosciences Inc
Application Number:	US14/846,505
Patent Claims:	1. A method of treating bacterial vaginosis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the therapeutically effective amount of secnidazole is an amount of secnidazole that exhibits a maximum plasma concentration (Cmax) of about 34.5 μg/ml to about 58.3 μg/ml, or about 17.4 μg/ml to about 26.5 μg/ml in the subject, wherein the microgranule formulation comprises a plurality of microgranules having a particle size in the range of 400 micrometers to 841 micrometers, and wherein secnidazole is the sole drug in the microgranule formulation. 2. The method of claim 1, wherein the therapeutically effective amount of secnidazole in the microgranule formulation is administered orally. 3. The method of claim 1, wherein the microgranule formulation further comprises at least one compound selected from a group consisting of sugar spheres, povidone, polyethylene glycol, ethyl acrylate methyl methylacrylate copolymer, and talc. 4. The method of claim 1, wherein the microgranule formulation is administered to a subject by mixing or combining it with a food substance. 5. The method of claim 1, wherein the subject is a female. 6. The method of claim 1, wherein the subject is a pregnant female. 7. The method of claim 1, wherein the subject is a female who had 3 or more bacterial vaginosis infections or episodes in the past 12 months. 8. The method of claim 1, wherein the subject is a female who had 4 or more bacterial vaginosis infections or episodes in the past 12 months. 9. The method of claim 1, wherein the subject is a female presenting with each of thin, homogeneous vaginal discharge, a positive KOH Whiff test, vaginal fluid pH greater than or equal to 4.7, and the presence of clue cells greater than 20% of total epithelial cells. 10. The method of claim 1, wherein the subject is a female with confirmed bacterial vaginosis. 11. The method of claim 10, wherein the female with confirmed bacterial vaginosis presents thin, homogeneous vaginal discharge, a positive KOH Whiff test, vaginal fluid pH greater than or equal to 4.7, presence of clue cells greater than 20% of total epithelial cells and a gram stain slide Nugent score equal to or higher than four on bacterial analysis of vaginal samples. 12. The method of claim 1, wherein the subject is a female with suspected bacterial vaginosis. 13. The method of claim 12, wherein the female with suspected bacterial vaginosis presents thin, homogenous vaginal discharge, a positive KOH Whiff test, vaginal fluid pH greater than or equal to 4.7, and presence of clue cells greater than 20% of total epithelial cells. 14. The method of claim 1, wherein the therapeutically effective amount of secnidazole in a microgranule formulation is administered as a single dose. 15. The method of claim 14, wherein the therapeutically effective amount of secnidazole in a microgranule formulation administered as a single dose is the only dose required to be administered to the subject to achieve a post treatment clinical outcome, resolution of one or more symptoms of bacterial vaginosis, or a combination thereof. 16. The method of claim 1, wherein the therapeutically effective amount of secnidazole in a microgranule formulation is 2 grams. 17. A method of treating bacterial vaginosis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the therapeutically effective amount of secnidazole is an amount of secnidazole that exhibits a time to maximum plasma concentration (Tmax) of about 3 hours to about 4 hours in the subject, wherein the microgranule formulation comprises a plurality of microgranules having a particle size in the range of 400 micrometers to 841 micrometers, and wherein the secnidazole is the sole drug in the microgranule formulation. 18. A method of treating bacterial vaginosis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the therapeutically effective amount of secnidazole is an amount of secnidazole that exhibits a time to maximum plasma concentration (Tmax) of about 2 hours to about 6 hours in the subject, wherein the microgranule formulation comprises a plurality of microgranules having a particle size in the range of 400 micrometers to 841 micrometers, and wherein secnidazole is the sole drug in the microgranule formulation. 19. The method of claim 1, wherein the therapeutically effective amount of secnidazole in a microgranule formulation is co-administered with an additional compound selected from ethinyl estradiol, norethindrone, or a combination thereof. 20. The method of claim 1, further comprising determining a post-treatment clinical outcome. 21. The method of claim 20, wherein the post-treatment clinical outcome is indicative of a clinical outcome responder. 22. The method of claim 21, wherein the clinical outcome responder is a subject with decreased thin, homogenous vaginal discharge relative to pre-treatment, a negative KOH Whiff test and clue cells less than 20% of total epithelial cells after treatment. 23. The method of claim 21, wherein the clinical outcome responder is a subject with a gram stain slide Nugent score of less than four after treatment. 24. The method of claim 21, wherein the clinical outcome responder is a subject with decreased thin, homogenous vaginal discharge relative to pre-treatment, a negative KOH Whiff test, clue cells less than 20% of total epithelial cells, and a gram stain slide Nugent score of less than four after treatment. 25. The method of claim 1, wherein the therapeutically effective amount of secnidazole in a microgranule formulation is mixed into a food substance. 26. The method of claim 19, wherein the additional compound is administered on the same day as the therapeutically effective amount of secnidazole in a microgranule formulation. 27. The method of claim 19, wherein the additional compound is administered on a different day than the therapeutically effective amount of secnidazole in a microgranule formulation. 28. The method of claim 1, wherein the secnidazole microgranule formulation does not affect the contraceptive efficacy of an additional compound selected from ethinyl estradiol, norethindrone, or a combination thereof. 29. The method of claim 1, wherein the subject has a resolution of one or more symptoms of bacterial vaginosis within up to about seven days after administration. 30. The method of claim 1, wherein the subject has an alleviation of one or more symptoms of bacterial vaginosis within up to about three days after administration.