ISSUE 1543
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The FDA has approved secnidazole oral granules (Solosec – Symbiomix/Lupin) for single-dose treatment of bacterial vaginosis (BV) in adult women.
THE NEW DRUG — Secnidazole is a nitroimidazole antimicrobial with a longer half-life than metronidazole (17 vs 8 hours). It has been available for decades in many other countries for treatment of BV, trichomoniasis, and other infections.1
BACTERIAL VAGINOSIS — In patients with BV, hydrogen peroxide-producing lactobacilli in vaginal flora are replaced by an overgrowth of other bacteria, including anaerobes such as Gardnerella vaginalis, which leads to production of malodorous amines and an increase in vaginal secretions. Patients with BV are often asymptomatic, but vaginal discharge and/or a fishy vaginal odor can occur. In the US, the prevalence of BV is 29% among all women
... more- P Nyirjesy and JR Schwebke. Secnidazole: next-generation antimicrobial agent for bacterial vaginosis treatment. Future Microbiol 2018 Jan 12 (epub).
- JE Allsworth and JF Peipert. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstet Gynecol 2007; 109:114.
- Drugs for sexually transmitted infections. Med Lett Drugs Ther 2017; 59:105.
- CS Bradshaw and JD Sobel. Current treatment of bacterial vaginosis – limitations and need for innovation. J Infect Dis 2016; 214 (Suppl 1):S14.
- SL Hillier et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol 2017; 130:379.
- JR Schwebke 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. Am J Obstet Gynecol 2017; 217:678.
- JM Bohbot et al. Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole. Infect Dis Obstet Gynecol 2010 Sep 15 (epub).
- SE Chavoustie et al. 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. J Womens Health (Larchmt) 2018 Jan 11 (epub).
- HS Pentikis et al. Lack of a pharmacokinetic interaction between SYM-1219 granules containing 2 grams of secnidazole and a combined oral contraceptive in a phase 1, randomized, open-label study in healthy female volunteers. Adv Ther 2017; 33:2229.
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