The Food and Drug Administration (FDA) has expanded the approval of Solosec® (secnidazole) to include treatment of female patients 12 years of age and older with bacterial vaginosis and for the treatment of trichomoniasis in all patients 12 years of age and older. Previously, the treatment was approved only in adult patients.
The expanded approval was based on data from a multicenter, open-label phase 4 study (ClinicalTrials.gov Identifier: NCT03937869) that evaluated the safety and tolerability of a 2g single oral dose of Solosec in 40 patients 12 to less than 18 years of age with bacterial vaginosis. The overall safety findings of Solosec in pediatric patients were found to be consistent with those observed in adult patients. Adverse reactions occurring in at least 1 patient included nausea and abdominal pain.
Additionally, the safety and efficacy of Solosec for the treatment of trichomoniasis in pediatric patients was based on the extrapolation of clinical trial data from adult women with trichomoniasis, 4 open-label trials in males with trichomoniasis, and an open-label safety study in pediatric female patients with bacterial vaginosis.
The recommended dosage of Solosec for bacterial vaginosis and trichomoniasis is a single 2-gram packet of granules taken once orally. Since trichomoniasis is a sexually transmitted disease, sexual partners should be treated with the same dose and at the same time.
Solosec is supplied as oral granules in single 2g unit-of-use child-resistant packets.
“The FDA’s approval expands the indication for Solosec® to treat adolescents and builds upon our commitment to support women’s health. This expansion brings to health care professionals a treatment option for both [bacterial vaginosis] and trichomoniasis in adolescents which provides a complete course of therapy in a single dose[…],” said Tom Merriam, Executive Director – Specialty, Lupin.
- Lupin announces FDA approval of supplemental New Drug Application for Solosec® (secnidazole) in adolescents for both the treatment of bacterial vaginosis in females and trichomoniasis. News release. Lupin Pharmaceuticals Inc. Accessed February 17, 2022. https://www.prnewswire.com/news-releases/lupin-announces-fda-approval-of-supplemental-new-drug-application-for-solosec-secnidazole-in-adolescents-for-both-the-treatment-of-bacterial-vaginosis-in-females-and-trichomoniasis-301484838.html
- Solosec. Package insert. Lupin Pharmaceuticals Inc; 2022. Accessed February 17, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209363Orig1s014s016lbl.pdf