Pharma Focus Asia

Symbiomix Therapeutics Submits New Drug Application to US FDA for Solosec™

Friday, January 20, 2017

Symbiomix, a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections, today announced submission of a new drug application (NDA) for Solosec™ (secnidazole oral granules) for the treatment of bacterial vaginosis (BV) to the US 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 & 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 (SYM-1219-201 and SYM-1219-301) 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.

magazine-slider-imageCytiva - Supor Prime filtersMFA + MMA 20244th Annual Cleaning Validation 20242nd Annual Pharma Impurity Conclave 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference