FDA approves Symbiomix Therapeutics’ Solosec for bacterial vaginosis
Symbiomix Therapeutics announced the FDA has approved Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Solosec is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that’s been shown to be efficacious and well tolerated. Solosec is the first and only single-dose oral therapy for BV, the most common gynecologic infection in the U.S.
“The FDA’s approval of this first-of-its-kind treatment is an important milestone for Symbiomix and most importantly, millions of women suffering from BV,” said David L. Stern, CEO of Symbiomix. “The approval of Solosec represents a critical moment in our efforts to bring innovative medicines to the women’s health market. Solosec is the first new oral antibiotic to treat BV in more than a decade and will provide women with a new treatment option. We look forward to making this treatment available to patients in the first quarter of 2018.”
BV is the most prevalent gynecologic infection in the U.S., affecting 21 million women ages 14 to 49 annually. The most commonly prescribed oral BV treatment regimen requires twice-a-day dosing for seven days. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50%. If left untreated, BV can increase the risk of contracting sexually transmitted diseases, including chlamydia, gonorrhea, herpes, trichomaniasis and HIV, and can also increase the risk of pre-term birth and low birth weight.
"The approval of Solosec finally gives women the option of a single, well-tolerated, oral dose treatment for BV, a common infection which can have many health consequences," said Paul Nyirjesy, M.D., Professor of Obstetrics & Gynecology at Drexel University College of Medicine in Philadelphia, Pennsylvania, and an investigator in the Solosec clinical trials. "A single dose regimen may improve adherence and the likelihood of a successful cure."
More than 50% of women treated for BV have a recurrence within 12 months, significantly impacting work productivity and quality of life. In recent studies, 60% of recurrent sufferers reported a negative impact on work attendance, job performance and productivity, and 95% reported a severe restriction in intimate partner relations.
“One in three women have been affected by BV, impacting their quality of life and potential for serious health risks,” said Beth Battaglino, RN, President & CEO of HealthyWomen, the leading independent, nonprofit health information source for women. “We are excited that for the first time ever, both frequent and infrequent BV adult women sufferers will now have a single-dose treatment option.”
The FDA approval was supported by a comprehensive set of studies, including two pivotal trials in BV and an open label safety study, which found efficacy for single-dose secnidazole 2g. All treatment-emergent adverse events were mild or moderate in intensity; no serious adverse events were reported, and no patients discontinued treatment due to adverse events.
The FDA 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 U.S. market exclusivity.