What is the role of secnidazole in the treatment of bacterial vaginosis (BV)?

Updated: Oct 25, 2018
  • Author: Philippe H Girerd, MD; Chief Editor: Michel E Rivlin, MD  more...
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Answer

In September 2017, the FDA approved the first single-dose oral treatment secnidazole (Solosec, Symbiomix Therapeutics) for women with bacterial vaginosis. [21]  Approval was based on two randomized, placebo-controlled studies which evaluated the efficacy of secnidazole in treatment of bacterial vaginosis. Efficacy was assessed by clinical outcomes evaluated 21-30 days following a single dose of secnidazole.  A clinical responder was defined as having "normal" vaginal discharge, negative "whiff" test, and clue cells <20%; additional endpoints included Nugent score cure and therapeutic outcome. 

In both trials, a statistically significantly greater percentage of patients experienced clinical response (Trial 1: 67.7%; Trial 2: 53.3%), Nugent score cure (Trial 1: 40.3%; Trial 2: 43.9%), and therapeutic response (Trial 1: 40.3%; Trial 2: 34.6%) at 21-30 days following a single dose of Solosec compared to placebo. [22, 23]


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