FDA approves supplemental NDA for secnidazole to treat trichomoniasis
The FDA this week approved a supplemental new drug application to expand the use of secnidazole to treat trichomoniasis in adults.
"The FDA's approval for the additional indication for Solosec (secnidazole, Lupin Pharmaceuticals) 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),” Jon Stelzmiller, who heads specialty business at Lupin Pharmaceuticals, said in a press release announcing the approval.
“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 sexually transmitted infections,” Stelzmiller said.
The approval was based on phase 3 clinical trial results that demonstrated clinically and statistically significant cure rates of 92.2% for patients with trichomoniasis treated with secnidazole (n = 64) compared with placebo (P < .001) in the modified intent-to-treat population, and 94.9% in the per-protocol population. The study also showed that cure rates were 100% among women with HIV and 95.2% in women with BV.
"Trichomoniasis is a highly prevalent STI that can increase an individual's risk for contracting or spreading other STIs, including HIV,” Steven Chavoustie, MD, FACOG, CCRP, obstetrician and gynecologist at the Segal Institute for Clinical Research, said in the release. “If left untreated, trichomoniasis can persist for months or years and result in adverse reproductive health outcomes, including infertility and preterm birth. For these reasons, screening and treatment for trichomoniasis is crucial and I am pleased that there is a new treatment option available to help meet the needs of this patient population."
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