International Journal of Gynecology & Obstetrics Publishes New Statement Focused on Unmet Needs of this Prevalent Medical Condition
NEWARK, N.J., March 6, 2017 – 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 field.
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 prescribing treatment.
“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 productivity .
- 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.
- 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 Jun 1;193(11):1478-86.
- 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 22(2010) 101-108.
- 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.