FDA Approves First Single-Dose Therapy for Bacterial Vaginosis
Secnidazole (Solosec) oral granules granted approval to treat bacterial vaginosis in adult women.
Officials with the FDA have approved secnidazole (Solosec, Symbiomix Therapeutics) 2 g oral granules to treat bacterial vaginosis (BV) in adult women, making it the first single-dose therapy for this condition, according to a press release.1
The FDA approval of this 5-nitroimidazole antimicrobial agent was supported by 2 studies of women with BV and an open label safety study, which found efficacy for single-dose secnidazole 2 g. 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, according to the study results.2,3
The FDA designated Solosec as a Qualified Infectious Disease Product for the treatment of BV and granted it Fast Track designation, which made Solosec eligible for priority review and at least 10 years of US market exclusivity.
BV is the most prevalent gynecologic infection in the US, affecting 21 million women ages 14 to 49 annually.4 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 preterm birth and low birth weight, according to CDC data.
1. FDA Approves Symbiomix Therapeutics’ Solosec™ (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women [news release] Newark, NJ. Symbiomix website. September 18, 2017. https://symbiomix.com/fda-approves-symbiomix-therapeutics-solosec-secnidazole-oral-granules-treatment-bacterial-vaginosis-adult-women/. Accessed September 18, 2017.
2. Hillier, SL, et al. Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial. Obstet Gyn. 2017; 130(2): http://journals.lww.com/greenjournal/Abstract/publishahead/Secnidazole_Treatment_of_Bacterial_Vaginosis__A.98347.aspx. Accessed September 18, 2017.
3. Schwebke, JR, et al. 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.” 2017; http://www.ajog.org/article/S0002-9378(17)30964-X/fulltext. Accessed September 18, 2017.
4. Koumans E.H.,Sternberg M, Bruce C, et al. (2007) “The Prevalence of Bacterial Vaginosis in the United States, 2001-2004: Associations with Symptoms, Sexual Behaviors, and Reproductive Health.” Sex Transm Dis. 34(11): 864-869.