Secnidazole has been approved for the treatment of trichomoniasis in adults by the Food and Drug Administration.
Drug manufacturer Lupin Pharmaceuticals recently made this announcement about the single-dose oral treatment. In 2017, secnidazole was approved for the treatment of bacterial vaginosis.
Trichomoniasis vaginalis is a common sexually transmitted infection that is nonviral and curable. Approximately 3 million to 5 million Americans are affected by trichomoniasis annually, and, if left untreated, the infection has the potential to harm reproductive health.
Risk factors associated with trichomoniasis and bacterial vaginosis include pelvic inflammatory disease and other sexually transmitted infections. The availability of secnidazole may help minimise these risk factors and improve adherence.
The FDA based their approval of secnidazole for trichomoniasis on data from a phase 3 clinical trial published in March 2021 in Clinical Infectious Diseases. Women with a confirmed trichomoniasis diagnosis were randomised, receiving either a single dose of 2 g oral secnidazole or a placebo. In comparison with the placebo, the use of secnidazole resulted in a 92.2% cure rate for the individuals with trichomoniasis. This cure rate was based on cultures collected between six and 12 days after receiving the dose. Subsets of patients with HIV and bacterial vaginosis showed cure rates of 100% and 95%.
2.7% of participants in the study reported the adverse events of vulvovaginal candidiasis and nausea. These two were the most common treatment-related adverse events reported by participants.
Secnidazole is FDA-approved for the treatment of trichomoniasis in both men and women. Data from four open-label studies, one involving men only and three involving both men and women, was also noted in the announcement.
