Vaginal health soon available over-the-counter

- in Forskning, In English, Nyheter

Researchers from Lund University are behind the design of a safer and more effective treatment for bacterial vaginosis. No prescription will be needed for the new drug, which will also eliminate many of the side effects of previous antibiotic treatments.

A group of researchers from Lund University stand behind the discovery that has catalyzed the development of a less invasive alternative treatment for bacterial vaginosis (BV). The treatment has already been authorized for sale in the European Union. The product, pHyph, comes in the form of a vaginal tablet, containing an oxidized form of glucose – a sugar that is naturally produced in the human body and would be safe to use as a food ingredient.

Helena Strevens, Gynecologist
Obstetrician and Associate
Professor at Lund University.
Photo: Private

Helena Strevens, Gynecologist Obstetrician, Associate Professor at Lund University and one of the researchers behind the new vaginal pill, says that about a third of all women every year develop bacterial vaginosis.

– It is a common condition, she says.

For some women it may recur with every menstruation, Helena Strevens continues.

The vaginal discharge for women with BV includes pathogenic bacteria, making it richer and foul-smelling. The shame around the symptoms of BV can prevent women from seeking help. pHyph will be available for purchase without prescription.

– Offering an over-the-counter product will make it easy for women to reduce the discomfort,  says Helena Strevens.  

According to the World Health Organization (WHO), bacterial vaginosis is a reaction to a proliferation of bad pathogens within the microbiome of the vagina that causes dysbiosis – an imbalance between beneficial and harmful bacteria. Untreated, it may result in pregnancy disruptions, an increased risk of developing HIV or other sexually transmitted infections and acquiring pelvic inflammatory disease. 

The WHO, while recognizing bacterial vaginosis as a treatable and curable condition, firmly states that BV is “best treated with the antibiotic metronidazole”. Helena Strevens notes that while antibiotics may initially work, they eventually wash away the vaginal flora. Antibiotics kill both good and bad bacteria – the good ones will have difficulties coming back and protecting the vaginal flora from the bad ones after the treatment. Studies have shown that 50-80% of patients treated with antibiotics for BV experienced a recurrence of symptoms within 6-12 months, and only 0-14% of patients treated with pHyph in different studies, says Helena Strevens. Developing secondary fungal infection was not recognized as a side effect after the pHyph treatment, compared to a 5,6-17% risk with the antibiotic treatment, she adds.

– Pathogens thrive in high pH, says Ulf Ellervik, Professor of Bioorganic Chemistry at Lund University who worked on the chemical development for the new BV treatment.

– The vaginal pill does two things, explains Helena Strevens.

Ulf Ellervik, professor of organic
chemistry at Lund University
Faculty of Engineering (LTH).
Photo: Private

She explains that it lowers the pH of the vagina, keeps it low, and increases the abundance of lactobacilli, the beneficial bacteria that produce lactic acid and further lower the pH levels.

– We produce an environment that the good bacteria like and the bad bacteria don’t like, adds Ulf Ellervik.

In the clinical trials for pHyph, 50% of patients said that their symptoms lessened within the first 24 hours; after 6 days, 70% of treated patients declared no symptoms at all, says Helena Strevens.

It has been almost a decade since four researchers from Lund University founded a spin-off company called Gedea Biotech to develop their product aiming to “provide both a quick relief and long-term cure” for bacterial vaginosis. Ulf Ellervik reflects that when they started working on pHyph, women’s health was not very advanced.

– In the last 10 years a lot has happened, he says.

– Almost all big companies work with women’s health now but they didn’t 10 years ago. Maybe we pushed the trend a little, and that’s important, Ulf Ellervik adds.

Almost a decade later, after clinical trials, struggles for obtaining patent rights and the CE marking from the European Commission, pHyph is ready for market.

– We hope that it will already be available next spring, says Helena Strevens.