The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) of Solosec (secnidazole oral granules; Symbiomix) for the treatment of bacterial vaginosis (BV).
The NDA submission was based on data from a comprehensive set of non-clinical and clinical studies including two pivotal Phase 3 trials, SYM-1219-201 and SYM-1219-301, in patients with BV. Results from clinical trials showed that a single, oral, 2 gram dose of Solosec was effective, safe, and tolerable for the treatment of BV.
Symbiomix submitted the NDA in January 2017. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of September 17, 2017 to make a decision on the NDA.
Solosec is a potent, next-generation 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties. The single-dose therapy could improve adherence in a condition where the current recommended regimen requires a twice-a-day dosing for 7 days.
For more information visit Symbiomix.com.