Secnidazole shows promise for recurrent BV treatment in new clinical trial

Secnidazole shows promise for recurrent BV treatment in new clinical trial | Image Credit: © wladimir1804 - © wladimir1804 - stock.adobe.com.

Further development of secnidazole oral granules (SOLOSEC; Evofem Biosciences, Inc.) for the treatment of bacterial vaginosis (BV) is supported by the results of a trial presented at the 2025 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting, according to Evofem Biosciences.

Efficacy of secnidazole for BV

The trial included 24 women with recurrent BV. These participants received a 2g dose of secnidazole oral granules once per week, displaying similar or potentially improved efficacy results compared to suppressive treatments currently recommended by the Centers for Disease Control and Prevention (CDC).

"These study results demonstrate that 2 g oral secnidazole granules… effectively suppressed recurrence of BV with recurrence rates equivalent to and possibly better than published study outcomes of current CDC-recommended suppressive treatments,” said Chemen M. Neal, MD, associate clinical professor at the Indiana University School of Medicine and lead investigator.

Prevalence and burden of BV

Approximately 29% of reproductive-aged women in the United States experience BV, making it the most common source of vaginal discharge in this population. Patients with this condition may also experience odor and irritation, often leading to embarrassment, social withdrawal, and reduced interest in relationships and physical activity.

Other adverse outcomes linked to BV include adverse birth outcomes, human immunodeficiency virus, other sexually transmitted infections, and pelvic inflammatory disease. Recurrence within 6 months has also been reported in up to 50% of women treated for BV.

Advantages of secnidazole granules

The trial highlights oral secnidazole granules as a potential simpler method for long-term management of BV symptoms. Administration is simplified because of the route of a single oral dose each week. This may improve rates of treatment adherence.

According to Evofem Biosciences, the negative outcomes linked to BV have led to increased interest in therapeutic options. This includes a projected market of $1 billion for BV treatments by 2033 in the United States because of increased incidence and public health awareness.

Limitations of current treatment modalities

This data was highlighted by Neal in an interview with Contemporary OB/GYN.² During the discussion, she noted the struggle many patients face when attempting to adhere to traditional BV regimens. These methods often involve daily oral antibiotic administration followed by twice-weekly doses.

BV may also be managed with intravaginal gels that can cause discomfort. In some cases, both oral and intravaginal treatment is provided, further increasing the risk of patients failing to adhere to the protocol. Secnidazole granules may be used to prevent these complications.

Neal also highlighted the current approval for oral secnidazole granules for treating acute, non-recurrent BV. However, this trial was one of the first to assess its efficacy against recurrent BV. The findings indicated secnidazole may be used for long-term treatment.

Clinical recommendations

The need for an accurate diagnosis of BV was also discussed, as patients are often misdiagnosed. According to Neal, evaluations should include detailed patient history, in-office microscopy, and proper use of testing modalities.

Neal concluded clinicians should employ these methods to ensure patients receive an accurate diagnosis, “and then when they do, to really partner with their patients and let them know that recurrent bacterial vaginosis can be difficult to get rid of, and that long-term suppressive therapy seems to be the best route.”

References

1. Notable data on Evofem's SOLOSEC in recurrent bacterial vaginosis (BV) released at ACOG Annual Meeting. Evofem. June 11, 2025. Accessed June 11, 2025. https://evofem.investorroom.com/2025-06-11-Notable-Data-on-Evofems-SOLOSEC-in-Recurrent-Bacterial-Vaginosis-BV-Released-at-ACOG-Annual-Meeting.
2. Neal CM. Chemen M. Neal, MD, discusses weekly secnidazole for bacterial vaginosis treatment. Contemporary OB/GYN. May 16, 2025. Accessed June 11, 2025. https://www.contemporaryobgyn.net/view/chemen-m-neal-md-discusses-weekly-secnidazole-for-bacterial-vaginosis-treatment.