FDA approves Symbiomix Therapeutics’ Solosec

SILVER SPRING, Md. — The Food and Drug Administration has approved Symbiomix Therapeutics’ new drug Solosec (secnidazole) oral granules. The drug is the first approved single-dose oral therapy for bacterial vaginosis. 

 

“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,” Symbiomix CEO David Stern said. “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. 

 

Bacterial vaginoses is estimated by to affect 21 million patients ages 19 to 49 years in the United States, and the most commonly prescribed treatment regimen requires twice-daily dosing for seven days. 

 

The company said Solosec would be available in the first quarter of 2018.