Evofem Announces First Patient Enrolled In A Clinical Trial To Determine The Effect And Duration Of Amphora Gel On Vaginal Ph
SAN DIEGO, Aug. 17, 2016 /PRNewswire/ -- Evofem, a biotechnology company focused on the development and commercialization of women's health products, has announced that patient enrollment has begun in their clinical study that will evaluate the effect and duration of Evofem's proprietary vaginal gel, Amphora for Bacterial Vaginosis (BV), on vaginal pH.
BV is an infection caused by an imbalance of bacteria in the vagina and is the most common vaginal infection in women ages 15-44..1 The etiology and pathogenesis of BV are not completely understood, and it is unclear whether the rise in vaginal pH that accompanies BV is a cause or effect of the microbial imbalance.2 Treatment of BV with antiobiotics often fails to correct the micro flora imbalance, therefore recurrence of BV is common.3,4 Current research suggests that Amphora for BV works through a novel mechanism of action with potential efficacy in helping to restore and maintain the proper balance of beneficial bacteria in the vagina.
"This proprietary vaginal gel is an acidity-maintaining gel which lowers the vaginal pH. With the first patient enrolled in the trial, we will be collecting data to determine the duration of its effect and the impact on the vaginal microbiome which will inform the design of future clinical trials," said Dr. David Friend, PhD., Senior Vice President of Research and Development and Technical Operations of Evofem.
"Millions of women suffer from the recurrence of bacterial vaginosis," said Saundra Pelletier, Evofem CEO. "Our innovative vaginal gel has the potential to be an important new treatment option for this pervasive issue that impacts the quality of life for so many women."
Evofem develops and commercializes innovative products that support and promote women as the primary healthcare consumer. Evofem is currently identifying and developing new and novel products that specifically address unmet needs in the areas of sexual and reproductive health, the prevention of acquisition of sexually transmitted infections and products that address or promote general health and wellbeing. Evofem has two lead product candidates: Amphora®, a vaginal contraceptive gel, and the Nestorone® Ring, a one-year contraceptive vaginal ring, both of which have completed Phase III clinical studies. For more information on the Company, visit www.evofem.com
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¹ Center for Disease Control and Prevention [CDC], 2013.
2 Ravel J, et al. Vaginal microbiome of reproductive age women. Proc. Natl. Acad. Sci. U. S. A. 2011. 108(Suppl1): 4680 4687.
3 Milani M., Barcellona E, Agnello A. Efficacy of the combination of 2 g oral tinidazole and acidic buffering vaginal gel in comparison with vaginal clindamycin alone in bacterial vaginosis: a randomized, investigator-blinded, controlled trial. Eur. J. Obstet. Gynecol. Reprod. Biol. 2003. 109:67-71.
4 Sobel, JD et al. Suppressive antibacterial therapy with 0.75% metronidazole vaginal gel to prevent bacterial vaginosis. Am. J. Obstet. Gynecol. 2006. 194:1283-1289.
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