Notable Data on Evofem's SOLOSEC in Recurrent Bacterial Vaginosis (BV) Released at ACOG Annual Meeting

Rhea-AI Summary

Evofem Biosciences (OTCPK: EVFM) presented promising study results for SOLOSEC (secnidazole) in treating recurrent bacterial vaginosis (BV) at the 2025 ACOG Annual Meeting. The clinical study of 24 women showed that once-weekly dosing of SOLOSEC 2g oral granules demonstrated efficacy comparable or potentially superior to current CDC-recommended suppressive treatments. BV affects approximately 21 million U.S. women, with up to 50% experiencing recurrence within six months of treatment. The BV treatment market is projected to reach $1.0 billion in the U.S. by 2033. While SOLOSEC is currently approved for BV treatment in women aged 12 and older, its use in recurrent BV remains investigational. The simplified once-weekly oral dosing regimen could potentially improve treatment adherence compared to more complex existing protocols.

Positive

• Study results show SOLOSEC's efficacy matches or potentially surpasses current CDC-recommended treatments
• Once-weekly oral dosing could improve patient adherence compared to complex existing treatments
• Large market opportunity with BV treatment market projected to reach $1.0 billion by 2033
• Addresses significant unmet need with BV affecting 21 million U.S. women

Negative

• Small study size of only 24 women may limit data reliability
• Recurrent BV indication still investigational and not yet FDA approved
• Company trades on OTCPK market rather than major exchange

Insights

Pharmaceutical Industry Analyst

Evofem's SOLOSEC shows promising results for recurrent BV, potentially expanding into a $1B market affecting 21M women.

The clinical study results for SOLOSEC in recurrent bacterial vaginosis (BV) represent a significant potential market expansion opportunity for Evofem. With the BV treatment market projected to reach $1 billion by 2033 and approximately 21 million women affected in the U.S. alone, this represents a substantial commercial opportunity.

The study's findings that once-weekly SOLOSEC dosing demonstrated efficacy matching or potentially surpassing current CDC-recommended treatments is particularly noteworthy. The simplified dosing regimen (once-weekly oral dose versus more complex alternatives) addresses a critical treatment adherence challenge in the recurrent BV space, where up to 50% of women experience recurrence within six months of treatment.

The market dynamics are compelling: high recurrence rates create a persistent treatment need, while existing therapies involve burdensome protocols combining daily oral antibiotics with intravaginal applications. SOLOSEC's potential to offer a simpler, effective alternative positions it well for market adoption if approved for this indication.

While SOLOSEC is currently approved only for initial BV treatment in women 12 and older, these results support its development for the recurrent BV indication. This represents a strategic pipeline expansion using an existing approved product, a typically lower-risk development approach compared to entirely new compounds. The planned submission to a peer-reviewed journal will be an important next step in building scientific credibility for this potential indication expansion.

-- BV Market Projected to Reach $1.0 Billion in the U.S. by 2033 --

-- BV Affects 21 Million U.S. Women; As many as 50% Experience Recurrent BV Within Six Months of Treatment --

SAN DIEGO, June 11, 2025 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. (OTCPK: EVFM) today announced that a study of SOLOSEC® (secnidazole) 2 g oral granules for recurrent bacterial vaginosis (BV) presented at the 2025 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting supports further development of SOLOSEC for the management of recurrent BV, a potential new indication.

In a focused clinical study of 24 women with recurrent BV, once-weekly dosing with secnidazole oral granules (SOLOSEC) demonstrated efficacy matching or potentially surpassing outcomes of current CDC-recommended suppressive treatments. These promising results underscore SOLOSEC's potential to redefine the standard of care for recurrent BV – offering a simpler treatment option for long-term symptom control. 

Chemen M. Neal, MD, associate clinical professor at the Indiana University School of Medicine and lead investigator of the study, notes, "These study results demonstrate that 2 g oral secnidazole granules, dosed once-weekly, effectively suppressed recurrence of BV with recurrence rates equivalent to and possibly better than published study outcomes of current CDC-recommended suppressive treatments. We also believe there may be improved adherence by women managing their recurrent BV with the once-weekly oral dosing versus other, more complicated treatment regimens."

BV is the most common cause of vaginal discharge in reproductive-age women, affecting approximately 29% of U.S. women, or roughly 21 million individuals. ^{1, 2}  Beyond discharge, BV symptoms include odor and irritation. These symptoms can lead to embarrassment, social withdrawal, and diminished interest in relationships and physical activity. The many consequential negative outcomes associated with BV include an increased risk of adverse birth outcomes, acquisition of human immunodeficiency virus and other STIs, and pelvic inflammatory disease. ³  

These dynamics are driving significant commercial interest in more effective and manageable therapies. StrategyHorizon Insights projects the market for BV treatments in the U.S. will reach $1.0 billion by 2033, propelled  by increasing BV incidence, greater public health awareness, and improvements in diagnostic approaches. 

Importantly, up to 50% of women who are treated for BV will experience a recurrence within six months, and nearly half will experience recurrence within one year of treatment  This high rate of symptomatic recurrence poses a substantial burden on the patents and the healthcare system alike.

A recent article in the journal 'Contemporary OB/GYN' notes that 'traditional treatment protocols for recurrent BV are burdensome, involving daily oral antibiotics followed by twice-weekly doses, or the use of intravaginal gels that can cause discomfort. Some regimens even combine oral and intravaginal treatments, making adherence particularly challenging,' and that 'many patients struggle with such complex regimens, especially over the extended periods needed for suppressive therapy.'

Once-weekly dosing of SOLOSEC represents a potential alternative to existing treatment regimens for recurrent BV. This approach involves a single oral dose each week, which may simplify administration and support treatment adherence. While SOLOSEC is currently approved for the treatment of BV in women aged 12 and older, its use in recurrent BV remains an investigational indication.

Dr. Neal presented the study, entitled 'Once Weekly Secnidazole Granules for the Treatment of Recurrent Bacterial Vaginosis,' at the ACOG Annual Meeting as an ePoster. She plans to submit the study for publication in a peer-reviewed journal. 

About SOLOSEC
SOLOSEC® (secnidazole) 2 g oral granules is a single dose oral 5-nitroimidazole drug. It is FDA-approved for the treatment of two sexual health diseases: Bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and Trichomonas vaginalis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. 

About Evofem Biosciences
Evofem Biosciences, Inc. is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company generates revenue from the sale of two FDA-approved products.

• PHEXXI^® (lactic acid, citric acid, and potassium bitartrate) is the first and only hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex.  
• SOLOSEC® (secnidazole) 2 g oral granules is an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. 

Evofem's commercial team relaunched SOLOSEC in November 2024, and promotes the product alongside PHEXXI to OB/GYNs in the U.S. The Company is entering global markets through strategic partnerships, including a license agreement with emerging Emirati company Pharma 1 Drug Store LLC under which PHEXXI and SOLOSEC are expected to launch in the UAE in 2026.

As previously announced, Evofem entered into a definitive agreement to be acquired by Aditxt, Inc. (Nasdaq: ADTX). Through the proposed acquisition of Evofem under the July 2024 Amended and Restated Merger Agreement between Evofem, Aditxt and Adifem, Inc., as amended (the "A&R Merger Agreement"), Aditxt aims to add a dedicated to women's health program to its social innovation platform accelerating promising health innovations. The companies are working toward a targeted close in the second half of 2025.

PHEXXI^® and SOLOSEC^® are registered trademarks of Evofem Biosciences, Inc.

Sources

1. Peebles K, Velloza J, Balkus JE, McClelland RS, Barnabas RV. High Global Burden and Costs of Bacterial Vaginosis: A Systematic Review and Meta-Analysis. Sex Transm Dis. 2019 May;46(5):304-311. doi: 10.1097/OLQ.0000000000000972. PMID: 30624309.
2. Koumans EH, Sternberg M, Bruce C, McQuillan G, Kendrick J, Sutton M, Markowitz LE. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis. 2007 Nov;34(11):864-9. doi: 10.1097/OLQ.0b013e318074e565. PMID: 17621244.
3. Muzny CA, Balkus J, Mitchell C, et al. Diagnosis and management of bacterial vaginosis: summary of evidence reviewed for the 2021 Centers for Disease Control and Prevention sexually transmitted infections treatment guidelines. Clin Infect Dis. 2022;74:Suppl_2:S144-S151.

Forward-Looking Statements
This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, "anticipate," "aim," "believe," "contemplate," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "seek," "should," "suggest," "strategy," "target," "will," "would," and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.  These statements include but are not limited to potential further evaluation of SOLOSEC for the investigational indication and potential outcomes thereof. The closing of the transaction with Evofem, Aditxt and Adifem, Inc., under the A&R Merger Agreement, as amended, is subject to several conditions including, but not limited to, 1) approval of the transaction by a majority of the combined voting power of Evofem's E-1 and Common Stock, voting together as a single class, at a meeting where quorum is present, and 2) Aditxt raising sufficient capital to fund its obligations at closing. These obligations include cash payments of approximately $17 million for Evofem, which includes approximately $15 million required to satisfy Evofem's senior secured noteholder. Should Aditxt fail to secure these funds, Evofem's senior secured noteholder is expected to seek to prevent the closing of the merger with Evofem. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that the transaction will ultimately close.  You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 24, 2025, amended on March 28, 2025, and any subsequent Form 10-Q filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.

Contact
Amy Raskopf
Chief Business Development Officer
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775

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SOURCE Evofem Biosciences, Inc.

FAQ

What were the key findings of Evofem's SOLOSEC study for recurrent bacterial vaginosis?

The study of 24 women showed that once-weekly dosing of SOLOSEC 2g oral granules demonstrated efficacy matching or potentially surpassing current CDC-recommended suppressive treatments for recurrent BV.

How many women are affected by bacterial vaginosis (BV) in the United States?

Approximately 21 million U.S. women (29% of women) are affected by bacterial vaginosis, with up to 50% experiencing recurrence within six months of treatment.

What is the projected market size for BV treatments by 2033?

According to StrategyHorizon Insights, the U.S. market for BV treatments is projected to reach $1.0 billion by 2033.

How does SOLOSEC's dosing differ from traditional BV treatments?

SOLOSEC offers a simplified once-weekly oral dose, compared to traditional treatments that require daily oral antibiotics, twice-weekly doses, or intravaginal gels.

Is SOLOSEC currently approved for treating recurrent bacterial vaginosis?

No, while SOLOSEC is approved for BV treatment in women aged 12 and older, its use in recurrent BV remains an investigational indication.