FDA approves secnidazole for treatment of trichomoniasis in adults
The U.S Food and drug administration (FDA) has approved an expanded indication for SOLOSEC (secnidazole) to include the treatment of trichomoniasis in adults patients and their partners. The drug has already been approved in 2017 for bacterial vaginosis (BV) in adult women.
The approval has been granted toLupin Pharmaceuticals, Inc.
SOLOSEC® is now the only single-dose oral prescription antimicrobial agent approved for the treatment of both BV and trichomoniasis in the U.S. Having a treatment option for patients with both of these infectious diseases 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 was based on a landmark Phase 3 clinical trial which demonstrated a 92.2% clinically and statistically significant cure rate for patients with Trichomoniasis – the most common non-viral, curable sexually transmitted infection in the U.S., affecting an estimated 3-5 million Americans every year.The data were recently published in Clinical Infectious Diseases in March 2021 and presented at the 2020 Infectious Diseases Society for Obstetrics & Gynecology (IDSOG) Virtual Annual Meeting.
The approval of Food and drug administration 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, Inc. 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 ."
If left untreated, trichomoniasis can persist for months or years and result in adverse reproductive health outcomes, including infertility and preterm birth. Therefore, screening and treatment for trichomoniasis is crucial.
For further reference log on to www.lupin.com/US/