NEWARK, N.J., Nov. 7, 2016 /PRNewswire/ -- Symbiomix, a biopharmaceutical company bringing innovative medicines to marketfor prevalent gynecological infections, today announced that data from studies of Solosec™ (secnidazole, also known as SYM-1219) oral granules will be presented at the 2016 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition
Details for the poster presentations are as follows:
Symbiomix recently announced that it is accelerating plans for the commercial launch of Solosec™, and the company is working towards a near-term submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). 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. Solosec™ is anticipated to be the first and only single-dose oral therapy approved for BV, which may lead to better adherence to therapy and therefore better patient outcomes. In clinical trials Solosec™ demonstrated efficacy for the treatment of BV with only a single, oral, two-gram dose, thereby additionally providing excellent safety, tolerability and adherence.
About Bacterial Vaginosis (BV)
BV is the most prevalent gynecological infection in the U.S. among women ages 15 to 44 [1,2]. Today more than four million women are treated in the US for BV annually . More than 50 percent of women treated for BV have a recurrence within 12 months .
The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks, including:
BV disproportionately affects disadvantaged populations, including women of color, and may contribute to persistent disparities in women's health outcomes [5,6].
BV has a significant impact on the work productivity and quality-of-life of affected women, with 60% of recurrent sufferers reporting a negative impact on work attendance, job performance and productivity, and 95% reporting a severe restriction in intimate partner relations [7,8].
The current recommended regimen of a first-generation nitroimidazole requires twice-a-day dosing for seven days for a total administration of seven grams of drug. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent . Poor adherence to anti-infective therapy is a problem that increases with the length and complexity of the drug regimen, and can lead to treatment failures, recurrent disease and the more rapid development of resistant microorganisms . These, in turn, may lead to higher health care costs, including increased out-of-pocket expenses, increased office visits and tests, additional treatment costs, and lost productivity .
About Symbiomix Therapeutics, LLC
Symbiomix (sim-bye-OH-mix) is a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections that can have serious health consequences. The Company's lead investigational drug Solosec™ (secnidazole) oral granules, a potent, next-generation 5-nitroimidazole antibiotic, is anticipated to be the first and only single-dose oral treatment approved for bacterial vaginosis (BV). Symbiomix was founded in 2012 by a team of experienced industry professionals and entrepreneurs and is backed by three of the world's leading healthcare venture capital firms: OrbiMed, F-Prime Capital Partners, and HBM Partners. Symbiomix is based in New Jersey, with additional offices in Maryland and Connecticut. Please visit www.symbiomix.com and follow the Company on LinkedIn and Twitter for more information.
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SOURCE Symbiomix Therapeutics
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