Pharma major Lupin has recently announced the launch of Solosec (secnidazole) 2g oral granules in the US market, having received an approval from the United States Food and Drug Administration (FDA) earlier.

Lupin’s Solosec (secnidazole) 2g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis (BV) in adult women.

Solosec, the first new oral antibiotic to treat BV in more than a decade, is designed to deliver a full course of therapy in a single 2g oral dose and is the first and only single-dose oral therapy for BV, the most common vaginal infection in the US among women of childbearing age.

The FDA approval of Solosec 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. Across both studies, Solosec was generally well tolerated with a low incidence of side effects.