International Journal of Gynecology & Obstetrics Publishes New
Statement Focused on Unmet Needs of this Prevalent Medical Condition
NEWARK, N.J.–(BUSINESS WIRE)–Symbiomix,
a women’s health biopharmaceutical company developing Solosec™
(secnidazole), a single-dose oral therapy for the treatment of bacterial
vaginosis (BV), is pleased to announce that the International Journal of
Gynecology & Obstetrics, the official publication of the International
Federation of Gynecology and Obstetrics (FIGO), has published a
consensus statement titled “State
of Bacterial Vaginosis: Experts Explore Unmet Needs Facing Women and
Providers” from nine leading experts in the bacterial vaginosis
In June of 2016, experts from across the country met to discuss the
unmet needs and pathways to improve the quality of care for women with
bacterial vaginosis, a prevalent gynecological infection that affects
more than 21 million U.S. women each year. Despite being the most
prevalent gynecological infection in the U.S., BV is underdiagnosed and
often misdiagnosed. When left untreated, women with BV are at a
significantly higher risk of serious health problems such as the
acquisition or transmission of sexually transmitted diseases like HIV,
pelvic inflammatory disease, and, if pregnant, a 100% increased risk of
pre-term birth. Currently, four million women are treated annually in
the U.S. for BV, and 50% of those treated experience recurrence of the
infection within one year. There has been limited research into new
treatment options which are desperately needed. According to a study
published by the American Sexually Transmitted Diseases Association,
only about 50% of patients adhere to the leading treatment option,
potentially due to side effects or length of treatment.
“Despite BV’s high prevalence, awareness is remarkably low among
patients and physicians,” said Joseph Amprey, MD, PhD, Co-founder, Head
of Medical Affairs and Chief Business Officer of Symbiomix.
“Underdiagnosis and misdiagnosis, in tandem with poor adherence to
treatment, exposes women to serious health risks. Symbiomix is
passionate about raising awareness surrounding BV and is working to
deliver better treatment options.”
The Statement highlights three key areas for improvement: the need for
greater visibility surrounding BV across healthcare providers, patients,
and advocacy groups, the significance of adopting point-of-care testing
for accurate diagnosis, and the importance of taking efficacy,
tolerability, adherence and patient satisfaction into consideration when
“It is our hope that the Statement will help to bring this pressing
women’s health issue to the forefront of provider and patient
conversations,” remarked Dr. Steven Chavoustie, MD, FACOG, CCRP,
Board-Certified Obstetrics and Gynecology. “Awareness and education are
key factors to ensuring proper diagnosis and effective treatment,
thereby preventing the serious health risks associated with BV.”
Symbiomix (sim-bye-OH-mix) is a biopharmaceutical company bringing
innovative medicines to market for prevalent gynecological infections
that can have serious health consequences. The Company’s lead
investigational medication Solosec™ (secnidazole) oral granules, (formerly
known as SYM-1219) a potent, next-generation 5-nitroimidazole
antibiotic, is anticipated to be the first and only single-dose oral
treatment approved for bacterial vaginosis (BV). Please visit www.symbiomix.com
and follow the Company on LinkedIn and Twitter for more information.
About Bacterial Vaginosis (BV)
BV is the most prevalent gynecological infection in the U.S. among women
ages 15 to 44 [1,2]. Today more than four million women are
treated in the US for BV annually . More than 50% of women
treated for BV have a recurrence within 12 months .
The U.S. Centers for Disease Control and Prevention (CDC) has stated
that BV can cause serious health risks, including:
- Increasing the risk of HIV transmission;
Increasing the risk of contracting other sexually transmitted
diseases, such as chlamydia and gonorrhea, which, if untreated, may
lead to pelvic inflammatory disease and infertility;
- In pregnant women, increasing the risk of delivering a baby too early .
BV disproportionately affects disadvantaged populations, including
women of color, and may contribute to persistent disparities in
women’s health outcomes [5,6].
BV has a significant impact on the work productivity and quality-of-life
of affected women, with 60% of recurrent sufferers reporting a negative
impact on work attendance, job performance and productivity, and 95%
reporting a severe restriction in intimate partner relations [7,8].
The current recommended regimen of a first-generation nitroimidazole
requires twice-a-day dosing for seven days for a total administration of
seven grams of drug. Adherence with the current leading therapy for the
treatment of BV has been shown to be only approximately 50% .
Poor adherence to anti-infective therapy is a problem that increases
with the length and complexity of the drug regimen, and can lead to
treatment failures, recurrent disease and the more rapid development of
resistant microorganisms . These, in turn, may lead to
higher health care costs, including increased out-of-pocket expenses,
increased office visits and tests, additional treatment costs, and lost
Allsworth J.E., Peipert, J.F. Prevalence of bacterial vaginosis:
2001-2004 National Health and Nutrition Examination Survey data.
Obstetrics and gynecology 2007;109:114-20.
|3.||IMS Health, 2014|
Bradshaw CS, et al. (2006). “High recurrence rates of bacterial
vaginosis over the course of 12 months after oral metronidazole
therapy and factors associated with recurrence” J Infect Dis. 2006
Fiscella, K. (1996). “Racial disparities in preterm births. The role
of urogenital infections.” Public Health Rep 111(2): 104-113.
Payne et al. (2010). “Evidence of African-American women’s
frustrations with chronic, recurrent bacterial vaginosis.” Jn AANP
Bilardi et al. (2013). “The Burden of Bacterial Vaginosis: Women’s
Experience of the Physical, Emotional, Sexual and Social Impact of
Living with Recurrent Bacterial Vaginosis.” PlusOne Sept 2013, vol
8, issue 9.
Bartley, J.B., et al. (2004). “Personal digital assistants used to
document compliance of bacterial vaginosis treatment.” Sex Transm
Dis 31(8): 488-491.
Kardas, P. (2002). “Once-Daily Dosage Secures Better Compliance With
Antibiotic Therapy of Respiratory Tract Infections Than Twice-Daily
Dosage.” WONCA Europe 2002 Conference, London.
Kardas, P., Bishai, W., (2006). “Compliance in anti-infective
medicine.” Adv Stud Med 2006; 6(7C):S652:S658.