FDA clears new indication for Lupin’s Solosec

Lupin’s Solosec (secnidazole oral granules) has a new indication. The Food and Drug Administration has approved expanding the drug’s use to include treatment of trichomoniasis in adults. 

The company noted that trichomoniasis vaginalis is the most common non-viral, curable sexually transmitted infection in the United States, affecting roughly 5 million people every year. The new indication joins Solosec’s initial approved indication — treatment of bacterial vaginosis in adults — and makes the drug the only single-dose oral microbial agent available by prescription to treat both conditions. 

"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,” said John Stelzmiller, president of specialty at Lupin. “Research demonstrates that approximately 70% of women with trichomoniasis are PCR positive for BV.”

The approval was based on trials that showed a cure rate of 92.2% of patients with trichomoniasis who were treated with Solosec. The drug can treat both patients with trichomoniasis and their partners, with the FDA approval including men based on four open-label studies that demonstrated cure rates ranging from 91.7% to 100% within a time range of two to 20 days. 

"Trichomoniasis is a highly prevalent STI that can increase an individual's risk for contracting or spreading other STIs, including human immunodeficiency virus. For approximately 70% of patients, trichomoniasis infection is asymptomatic,” said Dr. Steven Chavoustie, an obstetrician and gynecologist at the Segal Institute for Clinical Research. “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."