Symbiomix announced that the Food and Drug Administration (FDA) has granted Fast Track designation to SYM-1219 for the treatment of bacterial vaginosis (BV). Earlier this year, SYM-1219 also received Qualified Infectious Disease Product (QIDP) designation from the FDA for the same indication.
Symbiomix is currently evaluating SYM-1219 in a second Phase 3, multi-center, prospective, randomized, double-blind, placebo-controlled trial for the treatment of BV, which is expected to finish by the end of 2015. This would enable a New Drug Application (NDA) filing with the FDA in mid-2016.
SYM-1219 is a novel drug candidate containing secnidazole, a next-generation, 5-nitroimidazole antibiotic with favorable pharmacokinetics that facilitate administration as a single-dose oral therapy.
For more information visit Symbiomix.com.