Single-Dose Treatment for Bacterial Vaginosis Under Priority Review
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.