Bacterial Vaginosis: One in Three U.S. Women Have Been Affected by This Vaginal Infection That Can Have Serious Health Risks If Left Untreated

(BPT) - Over the course of their lives, many women experience symptoms of a vaginal infection, which can often be uncomfortable and confusing. What they may not know is that what they’re experiencing could be symptoms of bacterial vaginosis (BV) – one of the most prevalent gynecologic infections in the U.S., affecting 21 million women ages 14 to 49 annually. [1] It’s important for women to educate themselves about BV so they can best protect themselves from the associated health risks.

Caused by changes in the amount of certain types of bacteria in your vagina, BV can develop when your vagina has more harmful bacteria than good bacteria. [2] Common signs and symptoms associated with BV include unusual vaginal discharge that can be white or gray; watery; or have a strong fish-like odor. [2] These symptoms can easily be confused with those of a yeast infection. While discharge from a yeast infection may also be white or gray, it can look like cottage cheese, which is a key differentiator. [3]

“About thirty percent of reproductive age women have or have had BV. Left untreated, BV can have an impact on quality of life and increases the potential for other more serious health problems,” said Paul Nyirjesy, MD, Professor of Obstetrics & Gynecology at Drexel University College of Medicine in Philadelphia, PA and an investigator in the Solosec™ clinical trials.

Who Does BV Affect?

One in three women have been affected by BV, impacting more than 21 million in the U.S. each year, but only four million are treated annually. BV is most common among women ages 14 to 49; however, women of any age can get BV, even if they have never had sex. That said, having a new sex partner or multiple sex partners can upset the balance of bacteria in the vagina and this places a woman at an increased risk. Pregnant women are also susceptible to BV and it’s especially important that they receive treatment for the safety of their unborn baby. [1,2]

What Are the Risks?

According to the Centers for Disease and Control (CDC), if BV is left untreated, women are at risk for serious health concerns, including an increased risk of contracting sexually transmitted diseases, including chlamydia, gonorrhea, herpes, trichomaniasis and HIV; an increased risk of pre-term birth or low birth weight for pregnant women; and pelvic inflammatory disease. If you think you have BV, be sure to visit your healthcare provider to get tested and treated, as BV can only be treated with a prescription antibiotic. It’s important to take all the medicine prescribed to you, even if your symptoms go away. [2]

A New Treatment Option

Currently, the most commonly prescribed oral BV treatment regimen requires twice-a-day dosing for seven days and adherence with the leading therapies has been shown to be only approximately 50 percent. [4] Additionally, 60 percent of women treated for BV will likely have a recurrence within 12 months. [5]

Recently approved by the U.S. Food and Drug Administration (FDA), Solosec™ (secnidazole) 2g oral granules is the first and only single-dose oral therapy for BV in adult women. It offers women a one-time treatment option that can be taken any time of the day, with or without a meal. Solosec™ is clinically proven to normalize BV symptoms, odor and discharge, without the use of creams or week-long oral regimens. In clinical studies, the most common adverse events were (incidence ≥ 2%) yeast infection, headache, nausea, altered taste, vomiting, diarrhea, abdominal pain, and vaginal itching. [6]

To learn more about this new treatment option, visit www.solosec.com.

What is SOLOSEC?

SOLOSEC™ (secnidazole) 2g oral granules is a prescription medicine used to treat bacterial vaginosis in adult women.

Important Safety Information
  • You should not use SOLOSEC if you’ve had an allergic reaction to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.

  • Vaginal yeast infections may occur with SOLOSEC and require an antifungal treatment.

  • Long term use of SOLOSEC should be avoided as it is unclear if there is a potential risk of developing cancer while taking single-dose of SOLOSEC to treat bacterial vaginosis.

  • Before taking SOLOSEC, tell your healthcare provider about all of your medical conditions, including if you
    • Are pregnant or plan to become pregnant.
    • Are breastfeeding or plan to breastfeed. You should not breastfeed for 96 hours (4 days) after taking SOLOSEC.

  • SOLOSEC is a single-dose therapy for oral use. Use SOLOSEC by sprinkling an entire packet of SOLOSEC onto applesauce, yogurt, or pudding. The entire dose should be taken at once, and finished within 30 minutes. Avoid chewing or crunching the granules. SOLOSEC should not be taken by dissolving the granules in any liquid.

  • The most common side effects of SOLOSEC include yeast infection, headache, nausea, altered taste, vomiting, diarrhea, abdominal pain, and vaginal itching.

Call your doctor for medical advice on side effects. You are encouraged to report negative side effects of prescription drugs to FDA at www.fda.gov/MedWatch also at 1-800-FDA-1088 or contact Symbiomix Therapeutics at 1-844-SOLOSEC (1-844-765-6732).

Please click here for full Prescribing Information.

References:

1. Koumans E.H., Sternberg M, Bruce C, et al. (2007): “The Prevalence of Bacterial Vaginosis in the United States, 2001-2004: Associations with Symptoms, Sexual Behaviors, and Reproductive Health.” Sex Transm Dis. 34(11): 864-869.

2. http://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm.

3. Centers for Disease Control and Prevention. Genital / Vulvovaginal Candidiasis (VVC) – Fungal Diseases. 2014.

4. IMS Health, 2014.

5. Bilardi J.E., Walker S, Temple-Smith M, 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.” PLoS ONE. 8(9): 1-11.

6. Solosec [Package Insert]. Newark, NJ: Symbiomix Therapeutics, LLC.

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