Secnidazole ‘highly effective’ for trichomoniasis in US women
A single oral dose of secnidazole increased microbiological cure rates among women with trichomoniasis who were enrolled in a randomized controlled trial in the United States, including women with HIV or bacterial vaginosis.
Secnidazole was “highly effective” in the phase 3 trial, said Christina Muzny, MD, MSPH, FACP, FIDSA, associate professor of medicine in the division of infectious diseases at the University of Alabama at Birmingham.
The FDA has accepted Lupin Pharmaceuticals’ supplemental new drug application for secnidazole to treat trichomoniasis in adults and adolescents and set a target date of June 30 to announce a decision. If approved, it will be the only single-dose treatment available for both bacterial vaginosis (BV) and trichomonas in the U.S., Muzny said. The next-generation 5-nitroimidazole was approved by the FDA in 2017 for BV.
“This drug has been used to successfully treat women with trichomoniasis in Europe; however, it does not currently have FDA approval for this indication in the United States,” Muzny told Healio. “Thus, we were interested in studying secnidazole in U.S. women with trichomoniasis, which prompted us to conduct this study.”
Between April 2019 and March 2020, Muzny and colleagues randomly assigned 131 women with trichomoniasis to receive a single 2 g dose of oral secnidazole or placebo at 10 clinical sites in the U.S. The primary endpoint was microbiological test of cure (TOC) by culture 6 to 12 days after dosing. According to the study, at the TOC visit, participants were given the opposite treatment and were followed for resolution of infection afterward.
The 131 participants in the modified intent-to-treat (mITT) population included 64 women in the secnidazole group and 67 in the placebo group. Overall, the study demonstrated that cure rates were significantly higher in the secnidazole group compared with the placebo group in the mITT population (92.2%; 95% CI, 82.7%-97.4% vs. 1.5%; 95% CI, 0%-8%) and the per-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 frequently reported treatment-emergent adverse events were vulvovaginal candidiasis and nausea, the researchers reported.