Lupin Pharmaceuticals, the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) to expand the use of SOLOSEC (secnidazole) to include the treatment of trichomoniasis in adults.
Trichomoniasis vaginalis is the most common non-viral, curable sexually transmitted infection (STI) in the U.S., affecting an estimated three to five million people every year.1 SOLOSEC was approved in the U.S. in 2017 for the treatment of bacterial vaginosis (BV) in adult women. The supplemental approval makes SOLOSEC the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV.
“The FDA’s approval for the additional indication for SOLOSEC to treat trichomoniasis builds upon our commitment to support women’s health and provides health care professionals with an option to treat patients with trichomoniasis and bacterial vaginosis (BV).
Research demonstrates that approximately 70% of women with trichomoniasis are PCR positive for BV, said Jon Stelzmiller, President – Specialty, Lupin Pharmaceuticals. He also stated, “Additionally, having a treatment option for both trichomoniasis and BV that provides a complete course of therapy in a single dose will help address gaps in care related to adherence, and therefore, may reduce risk factors associated with trichomoniasis or BV, such as pelvic inflammatory disease (PID) and other STIs.”
The approval is based, in part, on trial results that demonstrated a clinically and statistically significant cure rate of 92.2% for patients with trichomoniasis treated with SOLOSEC (n=64) as compared to placebo (p<0.001) (n=67) in the modified intent-to-treat population, patients who had trichomoniasis and no other STIs (94.9% in the Per-Protocol population) in the landmark Phase 3 clinical trial. SOLOSEC was generally well-tolerated.
No serious adverse events were observed in the trial, and the most commonly reported adverse events were vulvovaginal candidiasis (2.7%) and nausea (2.7%). The data were recently published in Clinical Infectious Diseases in March 2021 and presented at the 2020 Infectious Diseases Society for Obstetrics & Gynaecology (IDSOG) Virtual Annual Meeting.