Journal
ARCHIVES OF GYNECOLOGY AND OBSTETRICS
Volume 306, Issue 1, Pages 101-108Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s00404-022-06429-z
Keywords
Bacterial vaginosis; Astodrimer sodium; Vaginal gel; Non-antibiotic treatment
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Funding
- Makara Health, UK - Mundipharma Medical GmbH, Switzerland
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Bacterial vaginosis (BV) is a common vaginal infection that greatly affects the physical, emotional, sexual, and social lives of women of childbearing age. Astodrimer sodium gel is a novel non-antibiotic treatment for BV that prevents pathogenic bacteria from adhering to the vaginal wall and inhibits the formation of bacterial biofilms. Clinical trials have shown higher cure rates and lower recurrence rates in patients treated with astodrimer sodium compared to placebo.
Bacterial vaginosis (BV) is the most common vaginal infection affecting women of childbearing age, and is associated with a substantial burden on women's physical, emotional, sexual and social lives, as well as being linked to a number of gynaecological and obstetrical complications and adverse pregnancy outcomes. Antibiotics, such as metronidazole or clindamycin, are recommended as first-line treatment for BV, but may be associated with antibiotic resistance, high rates of recurrence and poor patient treatment satisfaction. Astodrimer sodium gel is a novel, non-antibiotic treatment for BV that is not systemically absorbed. It prevents pathogenic bacteria from adhering to the vaginal wall, and disrupts and inhibits the formation of pathogenic bacterial biofilms. Clinical cure rates of 50-57% were observed in patients with BV treated with astodrimer sodium compared with 17-21% treated with placebo (p < 0.001) in Phase 3 trials. In a separate Phase 3 trial, recurrence of BV occurred in 44% of patients treated with astodrimer sodium compared with 54% of patients who received placebo (p = 0.015). Astodrimer sodium is well tolerated, with vulvovaginal candidosis being the only treatment-related adverse event reported to occur more often than with placebo. The availability of astodrimer sodium, a well-tolerated, convenient, non-antibiotic treatment for BV, represents significant progress in the treatment of this burdensome condition.
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