Lupin announces FDA Approval of Supplemental New Drug Application for SOLOSEC®

Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced today 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. 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, 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."

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 & Gynecology (IDSOG) Virtual Annual Meeting.

SOLOSEC® is now available for both treatment of patients and their partners.11 The FDA approval of SOLOSEC® for the treatment of trichomoniasis in men was granted based on four open-label trials in males; one comparative study with metronidazole and ornidazole in males only and three single-arm studies in males and females. Parasitological evaluation was performed both pre and posttreatment and reported cure rates ranging from 91.7% (165/180) to 100% (30/30) at time points ranging from two to 20 days (n=437, 211 males and 226 females).

"Trichomoniasis is a highly prevalent STI that can increase an individual's risk for contracting or spreading other STIs, including human immunodeficiency virus (HIV). For approximately 70% of patients, trichomoniasis infection is asymptomatic. If left untreated, trichomoniasis can persist for months or years and result in adverse reproductive health outcomes, including infertility and preterm birth," said Steven Chavoustie, M.D., FACOG, CCRP, Obstetrician and Gynecologist, Segal Institute for Clinical Research. He also stated, "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."

Since trichomoniasis is a sexually transmitted disease, sexual partners should be treated with the same dose and at the same time, to prevent reinfection. Prescribers may consider presumptively treating partners by expedited partner therapy (EPT) where allowed by law.

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