Evofem Biosciences has reported post-hoc analysis data from the Phase III AMPOWER clinical trial where Phexxi (lactic acid, citric acid, and potassium bitartrate) was shown to lower urinary tract infections (UTIs) in women.
An on-demand method of birth control, Phexxi, is used for the prevention of pregnancy.
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The single-arm, multicentre trial analysed the safety and efficacy of Phexxi to prevent pregnancy.
Among the 1339 women who took a minimum of one dose of Phexxi and were part of the safety population, 5.8% of them had an on-study UTI, compared to 11% in the general population.
Of these 5.8% women, one had an event classified as a ‘urinary tract infection bacterial’ while the rest had events categorised as UTIs.
The adverse events reported in the trial were in line with the data from the overall trial results.
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By GlobalDataEvofem CEO Saundra Pelletier said: “The Phase III AMPOWER study continues to provide data showing a larger and positive impact on a woman’s sexual, reproductive, and general health.
“Later this year will read out top-line data from our registrational Phase III EVOGUARD trial investigating Phexxi for the prevention of chlamydia and gonorrhoea, which, if approved, could further expand Phexxi’s opportunities to protect women’s health.”
In March this year, the company concluded subject enrolment in the registrational Phase III EVOGUARD trial of EVO100 for preventing chlamydia and urogenital gonorrhoea in women.
EVO100 is Phexxi’s investigational name.
The trial had target enrolment of 1730 subjects but, due to the increased demand, investigators enrolled a total of 1903 participants.
The company anticipates top-line results from the trial in the second half of this year.
