New BETADINE BV Gelis a new, non-antibiotic treatment distributed by Mundipharma South Africa, that has the potential to fulfil areas of unmet clinical need in the treatment of Bacterial vaginosis (BV).5A,6D
BV is the most common cause of abnormal vaginal discharge and has been associated with a range of serious health and reproductive consequences.1A,2A
Recurrent episodes of BV
Despite the availability of a number of oral and intravaginal antibiotic treatment options, its management remains challenging.1B More than 50% of women experience recurrent episodes with standard antibiotic-based treatments.1B,2A A key factor is the failure of antibiotics to fully eliminate vaginal biofilms adhered to cells lining the vagina that contain abundant Gardnerella vaginalis 1C, also known as bacterial vaginosis.
BV’s recurrent nature can have a substantial impact on women’s emotional, sexual and social lives.3A The most distressing symptom of BV is the distinctive, strong, fishy odour that accompanies a thin, grey or white vaginal discharge.3B,4A Women report feeling embarrassed, ‘dirty’ and concerned that others may detect the malodour.3C
Normalising vaginal pH
BETADINE BV Gel contains astodrimer sodium, a novel dendrimer-based therapy with a physical mechanism of action that disrupts vaginal biofilms and prevents harmful vaginal bacteria from adhering to vaginal lining, reducing their opportunity to grow whilst allowing normal vaginal flora to replenish.5A,6A,7A+B This helps to normalise the vaginal pH while relieving odour and discharge.5A
BETADINE BV Gel has proven clinical efficacy and safety in three large randomised trials in over 500 patients.6C,7C+D BETADINE BV Gel provides rapid relief from the unpleasant odour in just 24 hours.6B Because it acts locally and is not absorbed systemically, BETADINE BVGel avoids potential issues associated with conventional antibiotics such as systemic side effects, antibiotic resistance, and overgrowth of Candida is minimal.6A+E It has a favourable safety profile and is well tolerated.6C BETADINE BV Gel is applied once-daily for seven days.5B It is available over the counter (OTC) from Clicks and other leading pharmacies.
- Munzy CA, et al. Sex Transm Dis 2020;47(7):441-446.
- Happel A-U, et al. MedRxiv May 2020; https://doi.org/10.1101/2020.05.04.20090282.
- Bilardi JE, et al. PLoS ONE 2013;8(9):e74378.
- StatPearls. Bacterial Vaginosis. Available at: https://www.ncbi.nlm.nih.gov/books/NBK459216/. Accessed 20 November 2020.
- Betadine BV Gel IFU, April 2020.
- Chavoustie SE, et al. Eur J Obstet Gynecol Reprod Biol 2020;245:13-18.
- Data on file. Clinical Evaluation Report, July 2018, Starpharma Pty Ltd.