Solosec® (secnidazole) was assessed in two separate studies1-3

Study 1 Design

Study 1 enrolled 144 non-pregnant female patients aged 19 to 54 years. Efficacy was assessed by clinical outcome evaluated 21-30 days following a single dose of Solosec.

Study 2 Design

Study 2 enrolled 189 non-pregnant females aged 18 to 54 years. Efficacy was assessed by clinical outcome evaluated at 7-14 days and 21-30 days following a single dose of Solosec.

In these studies, Solosec demonstrated statistically significant efficacy in primary and secondary endpoints1-3

68% of patients on Solosec were more likely to require no additional BV treatment1,3

Solosec demonstrated statistically significant efficacy in the primary endpoint and in a post-hoc analysis, as shown in this graph.

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REFERENCES:

  1. SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2017.
  2. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2017;130(2):379-386.
  3. Schwebke JR, Morgan FG Jr, Koltun W, Nyirjesy P. A phase-3, double-blind, placebo-controlled study of the effectiveness and safety of single oral doses of secnidazole 2 g for the treatment of women with bacterial vaginosis. Am J Obstet Gynecol. 2017;217(6):678.e1-678.e9. doi: 10.1016/j.ajog.2017.08.017.