Evofem’s Phase III trial reveals fewer UTIs in women using Phexxi

pharmafile | May 9, 2022 | News story | Sales and Marketing  

Evofem has announced new data from the Phase III AMPOWER clinical trial of Phexxi (lactic acid, citric acid, and potassium bitartrate), which revealed that women who enrolled in the AMPOWER trial had fewer urinary tract infections (UTIs) compared to the general population. 

Of the 1339 women who self-administered at least one dose of Phexxi and were included in the safety population, 77 (5.8%) experienced an on-study UTI. Of the 77 women who experienced UTIs, one woman experienced an event that was classified as “urinary tract infection bacterial”. The remaining 76 women had events classified as “urinary tract infection”.

“In this post hoc analysis women who used Phexxi experienced significantly fewer UTIs compared to the general population,” said Dr Bassem Maximos, lead author of the study and Head of Maximos Ob/Gyn in League City, Texas. “These data provide insights worthy of further investigation to determine if Phexxi has an impact on UTIs in women.”

“The Phase III AMPOWER study continues to provide data showing a larger and positive impact on a woman’s sexual, reproductive, and general health,” said Saundra Pelletier, CEO of Evofem. “Later this year will read out top-line data from our registrational Phase III EVOGUARD trial investigating Phexxi for the prevention of chlamydia and gonorrhea, which, if approved, could further expand Phexxi’s opportunities to protect women’s health.”

Lina Adams

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