This page is intended to provide scientific information to research and healthcare professionals regarding SOLOSEC® (secnidazole) 2 g oral granules.
SOLOSEC was approved by the U.S. Food and Drug Administration in September 2017 for the treatment of bacterial vaginosis (BV) in adult women. The FDA later expanded its label in July 2021 to include the treatment of trichomoniasis in adults and their partners and, in February 2022, for the treatment of both BV and trichomoniasis in adolescents 12 and older. Evofem accquired SOLOSEC in July 2024.
| Indication | Author(s) | Publication | Title | Date |
|---|---|---|---|---|
| Recurrent BV | Neal et al. | Obstetrics & Gynecology Annual Clinical and Scientific Meeting of the American College of Obstetricians & Gynecologists (ACOG) | Once-Weekly Secnidazole Granules for the Treatment of Recurrent Bacterial Vaginosis [ID 775] | June 2025 in press May 2025 poster presentation |
| Trichomoniasis | Muzny et al. | BMJ Open | Efficacy of single-dose oral secnidazole for the treatment of trichomoniasis in women co-infected with trichomoniasis and bacterial vaginosis: a post hoc subgroup analysis of phase 3 clinical trial data. | August 2023 |
| Trichomoniasis | Muzny et al. | Clinical Infectious Diseases | Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study | September 2021 |
| Trichomoniasis | Muzny et al. | 2020 Infectious Diseases Society for Obstetrics & Gynecology (IDSOG) Virtual Annual Meeting | A Phase 3, multi–center, prospective, randomized, placebo–controlled, delayed treatment, double–blind study to evaluate the effectiveness and safety of a single oral dose of 2 grams of secnidazole for the treatment of trichomoniasis in women | August 2020 |
| Treatment of BV | Chavoustie et al. | Journal of Women’s Health | A Phase 3, Multicenter, Prospective, Open-Label Study to Evaluate the Safety of a Single Dose of Secnidazole 2 g for the Treatment of Women and Postmenarchal Adolescent Girls with Bacterial Vaginosis | April 2018 |
| Treatment of BV | Hillier et al. | Obstetrics and Gynecology | Secnidazole Treatment of Bacterial Vaginosis A Randomized Controlled Trial | August 2017 |
| Treatment of BV | Schwebke et al. | American Journal of Obstetrics and Gynecology | A phase-3, double-blind, placebo-controlled study of the effectiveness and safety of single oral doses of secnidazole 2 g for the treatment of women with bacterial vaginosis | December 2017 (Presented in oral format at the 43rd annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology August 2016) |
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