Solosec (secnidazole oral granules) filed with FDA for bacterial vaginosis- Symbiomix

Symbiomix has announced submission of a new drug application (NDA) for Solosec (secnidazole oral granules) for the treatment of bacterial vaginosis (BV) to the US FDA. Solosec is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, and is anticipated to be the first and only single-dose oral therapy approved for BV.

The NDA is supported by data from a comprehensive set of non-clinical and clinical studies conducted by Symbiomix, including the two pivotal trials in BV (SYM-1219-201 and SYM-1219-301) presented at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meetings in 2015 and 2016, respectively.

Comment:The antibiotic is sold as Flagentyl in countries like the Congo and Vietnam. It also has a close structural resemblance to metronidazole--sold as Flagyl to treat bacterial infections--which is one of the standard antibiotics used for bacterial vaginosis (BV).A single oral dose has been shown to be effective against BV in a high percentage of cases, making it a superior drug to metronidazole, which requires multiple dosing and therefore has only a relatively low adherence rate among patients.