Evofem - Model EVO100 - Urogenital Chlamydia and Urogenital Gonorrhea in Women
EVO100 (the investigational name for Phexxi) is in development for two potential new indications, the prevention of urogenital chlamydia and urogenital gonorrhea in women, leveraging its vaginal pH modulator mechanism of action. Infection with these bacterial pathogens hEVO100 (the investigational name for Phexxi) is in development for two potential new indications, the prevention of urogenital chlamydia and urogenital gonorrhea in women, leveraging its vaginal pH modulator mechanism of action. Infection with these bacterial pathogens has been associated with a higher vaginal pH level. By maintaining a normal vaginal pH and working to keep vaginal pH in the 3.5-4.5 range, Phexxi creates an environment that is detrimental to their growth and proliferation.
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In October 2020, Evofem initiated EVOGUARD, a confirmatory Phase 3 clinical trial to evaluate the safety and efficacy of Phexxi for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhoeae infection in women. Top-line results are expected in the second half of 2022.
The Phase 2b AMPREVENCE study evaluating Phexxi for the prevention of chlamydia and gonorrhea met its primary and secondary endpoints, and the study showed that EVO100 was generally safe and well-tolerated 1. Results of this double-blinded, placebo-controlled trial were presented at the 2020 STD Prevention Virtual Conference (view poster) and published in March 2021 in the American Journal of Obstetrics and Gynecology.
EVO100 (Phexxi) has been granted Fast Track Designation for the prevention of chlamydia in women and the prevention of gonorrhea in women and is designated a Qualified Infectious Disease Product (QIDP) for both indications by the U.S. Food and Drug Administration
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