Symbiomix, a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections, has announced submission of a new drug application (NDA) for Solosec (secnidazole oral granules) for the treatment of bacterial vaginosis (BV) to the U S Food and Drug Administration (FDA). Solosec is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, and is anticipated to be the first and only single-dose oral therapy approved for BV.
“Following decades of little innovation, Solosec represents an important potential advancement in the treatment of women’s health infections,” commented Robert Jacks, president and cfo. “As a single-dose oral treatment, Solosec could improve adherence, potentially leading to better health outcomes for the millions of women suffering with BV.”
The NDA is supported by data from a comprehensive set of non-clinical and clinical studies conducted by Symbiomix, including the two pivotal trials in BV presented at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) annual meetings in 2015 and 2016, respectively.
Solosec has been designated a Qualified Infectious Disease Product (QIDP) by the FDA for the treatment of BV and received fast track designation from the agency in 2015, making Solosec eligible for priority review and at least 10 years of market exclusivity.
Solosec is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties. In clinical trials Solosec demonstrated efficacy for the treatment of BV with only a single, oral, two-gram dose, with excellent safety, tolerability and adherence.