FDA approves Solosec (secnidazole) for treatment of bacterial vaginosis.- Symbiomix Therapeutics.

Symbiomix Therapeutics announced the FDA has approved Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. The FDA approval was supported by a comprehensive set of studies, including two pivotal trials in BV and an open label safety study, which found efficacy for single-dose secnidazole 2g. All treatment-emergent adverse events were mild or moderate in intensity; no serious adverse events were reported, and no patients discontinued treatment due to adverse events.

Comment: The FDA designated Solosec as a Qualified Infectious Disease Product (QIDP) for the treatment of BV and granted it Fast Track designation, which made Solosec eligible for priority review and at least 10 years of U.S. market exclusivity.