FDA to Review Potential Single-Dose Therapy for Bacterial Vaginosis

The NDA submission is based on data from pivotal trials, SYM-1219-201 and SYM-1219-301
The NDA submission is based on data from pivotal trials, SYM-1219-201 and SYM-1219-301

Symbiomix announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Solosec (secnidazole oral granules) for the treatment of bacterial vaginosis (BV).

The NDA submission is based on data from the clinical development program for Solosec, including the pivotal trials SYM-1219-201 and SYM-1219-301 where it demonstrated its efficacy and safety for the treatment of BV with only a single, oral, 2g dose. Results from these studies were presented at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meetings. 

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The FDA previously granted Solosec Qualified Infectious Disease Product (QIDP) and Fast Track designations in 2015. If approved, Solosec would become the first and only single-dose oral therapy for BV.

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.