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# Symbiomix Agreement with FDA on Secnidazole NDA
- URL: https://www.fdaweb.com/symbiomix-agreement-with-fda-on-secnidazole-nda/
- Published: 2016-05-26T12:00:00.000Z
- Updated: 2026-09-14T21:05:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135769

Symbiomix says it had a successful pre-NDA meeting with FDA and has reached agreement with the agency on all aspects for an NDA filing in the fourth quarter of 2016 for its SYM-1219 (secnidazole) for treating bacterial vaginosis. The drug is described as a next-generation, 5-nitroimidazole antibiotic expected to be the first single-dose oral treatment approved for bacterial vaginosis. It has been designated by the agency as a Qualified Infectious Disease Product, making it eligible for priority review and at least 10 years of marketing exclusivity.

The company says that a Phase 3 trial comparing a single dose of SYM-1219 to placebo in 189 women who were both infrequent sufferers and patients with recurrent bacterial vaginosis achieved statistically and clinically significant results across all primary and secondary endpoints.