Findings of a new phase 3 trial support the use of secnizadole in patients with trichomoniasis.
Findings of a new study indicate the efficacy of secnidazole (Solosec) in female patients with trichomoniasis.
The study findings highlighted the importance of screening women at high risk and treated the with convenient and effective therapy.
“The efficacy results of the Phase 3 study are quite encouraging and could support the utility of Solosec in clinical practice as a treatment option for trichomoniasis once the new indication is approved," said Christina Muzny, MD, MSPH, from the University of Alabama at Birmingham.
The phase 3, multi-center, prospective, randomized, placebo-controlled, delayed treatment, double-blind study met its primary endpoint of microbiological cure at the test-of-cure visit on day 6-12. Investigators defined microbiological cure as a negative trichomoniasis vaginalis culture in the modified Intent-to-Treat population among those randomized who were culture positive for T. vaginalis and negative for gonorrhea and chlamydia at baseline.
Patients were randomized 1:1 to receive either secnidazole oral granules or placebo. All patients were evaluated for test-of-cure at the second visit (day 6-12). During visit 2, patients who received placebo at baseline were given active treatment with secnidazole.
Among the patients in the secnidazole group, 92.2% achieved the primary endpoint versus 1.5% in the placebo group (P <.001). The cure rate was 94.9% for patients who received secnidazole compared to 1.7% in the placebo group (P <.001).
Secnidazole was reportedly well-tolerated, with the most common adverse events including vulvovaginal candidiasis (2.7%) and nausea (2.7%). There were no serious adverse events observed.
Trichomoniasis increases the risk of HIV, disproportionally affects African American women, and can lead to adverse health outcomes. The condition is the most common non-viral sexually transmitted infection in the US and infects an estimated 3-5 million people. African American women have a nearly ten times higher risk of being affected compared to non-Hispanic white women.
Because of the success of the trial, Lupin Pharmaceuticals will submit a supplemental New Drug Application to the US Food and Drug Administration (FDA). Secnidazole is currently approved by the agency to treat bacterial vaginosis in adult women.
The study, “A Phase 3, multi–center, prospective, randomized, placebo–controlled, delayed treatment, double–blind study to evaluate the effectiveness and safety of a single oral dose of 2 grams of secnidazole for the treatment of trichomoniasis in women,” was presented at the 2020 Infectious Diseases Society for Obstetrics & Gynecology.