FDA Approves Expanded Indication for Secnidazole for Trichomoniasis

The FDA announced it approved an expanded indication for Solosec (secnidazole) to adult women and their partners for trichomoniasis.

The FDA approval’s of secnidazole for trichomoniasis treatment in men was granted based on 4 open-label trials in males; 1 comparative study with metronidazole and ornidazole in males only and 3 single-arm studies in males and females. Parasitological evaluation was performed both pre- and post-treatment and reported cure rates ranging from 91.7% (165/180) to 100% (30/30) at time points ranging from two to 20 days (n=437, 211 males and 226 females).

Secnidazole is currently the only single-dose oral prescription antimicrobial agent approved for the treatment of both BV and trichomoniasis in the US. Having a treatment option for patients with both of these infectious diseases that provides a complete course of therapy in a single dose will help address gaps in care related to adherence, and therefore, may reduce risk factors associated with trichomoniasis or BV, such as pelvic inflammatory disease (PID) and other STIs.

“The FDA's approval for the additional indication for Solosec to treat trichomoniasis builds upon our commitment to support women's health and provides health care professionals with an option to treat patients with trichomoniasis and bacterial vaginosis (BV). Research demonstrates that approximately 70% of women with trichomoniasis are PCR positive for BV," Jon Stelzmiller, president, Specialty, Lupin Pharmaceuticals, said. “Additionally, having a treatment option for both trichomoniasis and BV that provides a complete course of therapy in a single dose will help address gaps in care related to adherence, and therefore, may reduce risk factors associated with trichomoniasis or BVsuch as pelvic inflammatory disease (PID)[and other STIs.”.

The therapy was initially approved in 2017 for bacterial vaginosis (BV) in adult women.