Results from a pivotal phase 3 trial of secnidazole for the treatment of trichomoniasis were presented at the 2020 Infectious Diseases Society for Obstetrics & Gynecology (IDSOG) Virtual Annual Meeting.
The multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of secnidazole in 147 adult female patients with trichomoniasis. Patients were randomized to receive either a 2g single oral dose of secnidazole granules or placebo at visit 1 (baseline). After 6-12 days, patients were evaluated at the “test of cure” (TOC) visit. The primary end point was microbiological cure at the TOC visit.
Findings from the study showed that treatment with secnidazole resulted in clinically and statistically significant microbiological cure, defined as a negative Trichomonas vaginalis culture, vs placebo at the TOC visit (P <.001). The cure rate was 92.2% (n=59/64) for secnidazole vs 1.5% (n=1/67) for placebo in the modified intent-to-treat population, which included patients who tested positive for T. vaginalis and negative for gonorrhea and chlamydia at baseline. Additionally, in the per-protocol population, the cure rate was 94.9% (n=56/59) for secnidazole vs 1.7% (n=1/60) for placebo (P <.001).
As for safety, secnidazole was generally well tolerated with the most common adverse events being vulvovaginal candidiasis (2.7%) and nausea (2.7%). There were no serious adverse events observed.
Lupin Pharmaceuticals will submit a supplemental New Drug Application (sNDA) for the trichomoniasis indication later this year. Secnidazole is marketed under the brand name Solosec® and is currently approved for the treatment of bacterial vaginosis in adult women.
“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, University of Alabama at Birmingham, who presented the abstract at IDSOG. “Trichomoniasis increases the risk of HIV infection, disproportionately affects African American women and can lead to adverse health outcomes. It is critical to screen women at high risk and treat with therapy that is convenient to use, to help improve patient compliance.”
Solosec is supplied as oral granules in single 2g unit-of-use, child-resistant packets.
For more information visit lupin.com.
Lupin presents phase 3 data for Solosec® (secnidazole) demonstrating significant response rate in female patients with trichomoniasis. https://www.prnewswire.com/news-releases/lupin-presents-phase-3-data-for-solosec-secnidazole-demonstrating-significant-response-rate-in-female-patients-with-trichomoniasis-301112461.html. Accessed August 14, 2020.