Vaginal gel shows promise for chlamydia, gonorrhea prevention
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Evofem Biosciences announced that the vaginal gel Amphora demonstrated a 50% and 78% RR reduction for chlamydia and gonorrhea, respectively, in a phase 2b trial.
The trial, AMPREVENCE, evaluated the safety and efficacy of the vaginal gel for the prevention of urogenital chlamydia and gonorrhea in women.
“In 2018, the incidence of sexually transmitted infections rose for the fifth consecutive year in the United States,” an Evofem spokesperson told Healio. “The U.S. is dangerously close to untreatable gonorrhea, and infertility is one of most devastating potential consequences of chlamydia, yet there are no approved prescription products for the prevention of either infection.”
During the trial, 288 women used Amphora and 287 used a placebo vaginal gel for 4 months, according to the release. Among the women who used Amphora, the infection rate of chlamydia was 4.9% compared with 9.8% among those who used placebo (P = .024) — a 50% RR reduction, meeting the trial’s primary endpoint.
According to a secondary endpoint analysis, the gonorrhea infection rate was 0.7% among 280 women who used Amphora compared with 3.2% among 277 women who used a placebo (P = .03), for a 78% RR reduction.
No serious treatment-related adverse events were reported, and the number of adverse events were similar in both arms of the trial. Specifically, 7.2% of women in the Amphora group reported an adverse event compared with 7.5% of women in the placebo group.
The company reported that Amphora was generally safe and well tolerated, consistent with trial results for its use for pregnancy prevention. The company said it will be resubmitting a new drug application to the FDA that highlights both of these indications.
“The AMPREVENCE study not only demonstrated both robust efficacy and safety but also achieved both primary and secondary endpoints in RR reduction [for] chlamydia and gonorrhea, providing evidence of a viable option to help stem this public health crisis,” the spokesperson said. “If approved by the U.S. Food and Drug Administration, Amphora could be the first new female-controlled intervention with the potential to address two significant unmet needs — nonhormonal prevention of pregnancy and prevention of chlamydia and gonorrhea infection.” – by Marley Ghizzone
Perspective
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Jeanne M. Marrazzo, MD, MPH, FACP, FIDSA
I am always cautious in reacting to “top-line” press releases because that is exactly what they are — the “top-line” as opposed to the “bottom line”! For the latter, we really need to see the data. A thorough interpretation of what the study showed should await formal presentation at a scientific meeting. That said, this product has been available for a long time as a vaginal lubricant, and some have used it as a vaginal acidifier (to at least temporarily normalize the vaginal pH), so its safety profile should be OK (again, we’ll need to see the data). What I think is intriguing about this design is the component of using the gel pericoitally (with sexual intercourse). That could address some of the events that we think trigger the movement into vaginal dysbiosis.
We have no nonantibiotic options for maintaining normal vaginal pH, which is essential for sexual and reproductive health. Women can use suppressive antibiotics vaginally to do this, but they are expensive and not available in many parts of the world. Moreover, if the reduction in bacterial STI is real, that would be a major benefit — at least for women who do not desire pregnancy given the product’s profile.
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