FDA approves Symbiomix Therapeutics’ Solosec for bacterial vaginosis

Monday, September 18, 2017

Symbiomix Therapeutics announced the FDA has approved Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Solosec is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that’s been shown to be efficacious and well tolerated. Solosec is the first and only single-dose oral therapy for BV, the most common gynecologic infection in the U.S.

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Symbiomix completes SYM-1219 enrollment

Monday, August 31, 2015

Symbiomix has completed patient enrollment in a phase III clinical study, the second pivotal trial of SYM-1219, a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV). Earlier this year Symbiomix announced positive results from the first pivotal trial for SYM-1219. Symbiomix expects to finish the second pivotal trial by the end of 2015, which would enable an NDA filing with the FDA in mid-2016.

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