FDA: First Single-Dose Treatment for Bacterial Vaginosis

The US Food and Drug Administration (FDA) has recently approved Solosec (secnidazole) for the treatment of adult women with bacterial vaginosis (BV). This is the first and only single-oral dose therapy for BV approved by the FDA.

Solosec is administered orally by sprinkling the contents of the packet (2 g granules) onto applesauce, yogurt, or pudding and consuming it within 30 minutes without chewing or crunching the granules.
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Approval for Solosec was based on a comprehensive set of studies that included 2 pivotal trials and an open-label safety study, which found the antibiotic to be safe and effective for treating BV.

Common adverse events associated with Solosec include vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus. All adverse events associated with treatment were mild or moderate, and no patient discontinued treatment due to adverse events.

—Melissa Weiss

Reference:

FDA approves Symbiomix Therapeutics’ Solosec™ (secnidazole) oral granules for the treatment of bacterial vaginosis in adult women [press release]. Newark, NJ: Symbiomix Therapeutics, September 18, 2017. https://symbiomix.com/fda-approves-symbiomix-therapeutics-solosec-secnidazole-oral-granules-treatment-bacterial-vaginosis-adult-women. Accessed September 18, 2017.