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# FDA Accepts Sybiomix NDA for Antibiotic
- URL: https://www.fdaweb.com/fda-accepts-sybiomix-nda-for-antibiotic/
- Published: 2017-03-23T12:00:00.000Z
- Updated: 2026-09-14T22:13:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138274

FDA has accepted for review a Symbiomix NDA for its lead investigational product candidate Solosec (secnidazole oral granules), an antibiotic designed to treat bacterial vaginosis (BV). The agency has granted a six-month priority-review designation with a user fee review target date of 9/17.

The company described Solosec as a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties. FDA previously designated Solosec as a Qualified Infectious Disease Product for treating BV and granted it a fast track designation, which made Solosec eligible for at least 10 years of market exclusivity, Symbiomix says.

  
The NDA was supported by two pivotal trials in BV (SYM-1219-201 and SYM-1219-301), results from which were presented at the Infectious Diseases Society for Obstetrics and Gynecology annual meetings in 2015 and 2016, respectively. “In clinical trials Solosec demonstrated efficacy for the treatment of BV with only a single, oral, two-gram dose, with excellent safety, tolerability and adherence,” the company says.