Orylnvah is a broad-spectrum oral penem antibiotic for women who have limited or no alternative treatment options, according to an Oct. 24 FDA news release.
In trials, Orylnvah had a 62% composite response rate, compared to 55% composite response rate in patients treated with amoxicillin/clavulanate. It also was found to be superior to ciprofloxacin, with a 48% composite response rate compared to 33% in the ciprofloxacin group.
The most common side effects were diarrhea, nausea, vaginal yeast infection, headache and vomiting, the release said.
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