Symbiomix today announced that the US Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for its lead investigational product candidate Solosec™ (secnidazole oral granules), an innovative antibiotic designed to treat bacterial vaginosis (BV). In accordance with the FDA’s priority 6-month review designation, the agency has established a user-fee goal date under the Prescription Drug User Fee Act (PDUFA) of September 17, 2017. Symbiomix submitted the NDA filing in January 2017.
Solosec™ is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, which will be the first and only single-dose oral therapy approved for BV if approved by the FDA. The FDA previously 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 market exclusivity.