Infectious Disease

Secnidazole “highly effective” against trichomoniasis in American women

April 07, 2021

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Disclosure:
Muzny reports numerous ties to industry, including supporting research grants and honoraria from Lupine Pharmaceuticals and serving as a consultant for Lupine Pharmaceuticals. In the study you will find all relevant financial information from all other authors. Source: Muzny CA, et al. Clin Infect Dis. 2021; doi: 10.1093 / cid / ciab242.

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A single oral dose of secnidazole increased microbiological cure rates in women with trichomoniasis participating in a randomized controlled trial in the United States, including women with HIV or bacterial vaginosis.

Secnidazole was said to be “highly effective” in the Phase 3 study Christina Muzny, MD, MSPH, FACP, FIDSA, Associate Professor of Medicine in the Department of Infectious Diseases at the University of Alabama, Birmingham.

Trichomoniasis Infographic

Source: Muzny CA, et al. Clin Infect Dis. 2021; doi: 10.1093 / cid / ciab242.

The FDA has accepted Lupine Pharmaceuticals’ complementary new drug application for secnidazole for the treatment of trichomoniasis in adults and adolescents, with a target announcement date of June 30th. If approved, it will be the only single-dose treatment available for both bacterial vaginosis (BV) and trichomonas in the United States, Muzny said. The next generation 5-nitroimidazole was approved by the FDA for BV in 2017.

“This drug has been used successfully in Europe to treat women with trichomoniasis. In the USA, however, this indication is currently not approved by the FDA, ”said Muzny told Healio. “So we were interested in studying secnidazole in US women with trichomoniasis, which prompted us to conduct this study.”

Christina Muzny

Between April 2019 and March 2020, Muzny and colleagues randomly assigned 131 women with trichomoniasis a single dose of 2 g oral secnidazole or placebo at 10 clinical sites in the United States. The primary endpoint was the microbiological healing test (TOC) by culture 6 to 12 days after dosing. According to the study, when attending the TOC, participants received the opposite treatment and were then observed to resolve the infection.

The 131 participants in the modified intent-to-treat population (mITT) included 64 women in the secnidazole group and 67 in the placebo group. Overall, the study showed that the cure rates in the secnidazole group were significantly higher in the mITT population compared to the placebo group (92.2%; 95% CI, 82.7% -97.4% versus 1.5 %; 95% CI, 0% -8%) and the pro-protocol population (94.9%; 95% CI, 85.9-98.9 vs. 1.7%; 95% CI, 0-8 , 9).

The study also showed that cure rates were 100% (4/4) in women with HIV and 95.2% (20/21) in women with BV, and that secnidazole was well tolerated. The most commonly reported treatment-related adverse events were vulvovaginal candidiasis and nausea, the researchers reported.

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