Symbiomix’s lead product is Solosec™ (secnidazole) oral granules, formerly known as SYM-1219, a potent, next-generation investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, has shown effectiveness in clinical trials with significantly less total drug exposure than first generation nitroimidazoles, leading to excellent safety, tolerability and adherence.
In early 2017 Symbiomix submitted the NDA for Solosec™ as a single-dose oral therapy for the treatment of BV. The FDA has granted the application Priority Review. If approved, Solosec could be commercially available in early 2018.
Solosec™ is anticipated to be the first and only single-dose oral therapy approved for BV. In clinical trials Solosec™ has shown excellent efficacy, tolerability and adherence to treatment, which may lead to better patient outcomes.
Solosec™ has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of BV. QIDP designation creates incentives for the development of new drugs intended to treat serious or life threatening infections and makes Solosec™ eligible for certain benefits including at least 10 years of market exclusivity.
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