Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of Lupin Limited, announced today that the U.S. Food and Drug Administration (FDA) has accepted their supplemental New Drug Application (sNDA) for Solosec (secnidazole) for the treatment of trichomoniasis in adults and adolescents. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of June 30, 2021. Trichomoniasis vaginalis is the most common non-viral, curable sexually transmitted infection (STI) in the U.S., affecting an estimated 3 to 5 million people. Solosec 2 g oral granules is currently FDA-approved to treat bacterial vaginosis (BV) in adult women.

"The FDA acceptance of our application for Solosec to treat trichomoniasis is an important milestone for our company and for patients who are in need of new options for the treatment of trichomoniasis," said Jon Stelzmiller, President – Specialty, Lupin Pharmaceuticals, Inc. "We look forward to working with the FDA during their review of our file for this new indication."

If approved for trichomoniasis, Solosec could be the only single-dose oral prescription treatment for both BV and trichomoniasis.

The Solosec sNDA is based, in part, on trial results that showed a clinically and statistically significant response rate, or microbiological cure, in patients treated with Solosec as compared to placebo (p<0.001). In the Per-Protocol population, the cure rate was 94.9% (56/59) for Solosec versus 1.7% (1/60) for placebo (p<0.001). Solosec was generally well-tolerated. The most commonly reported adverse events were vulvovaginal candidiasis (2.7%) and nausea (2.7%). No serious adverse events were observed in the trial. The data were presented at the 2020 Infectious Diseases Society for Obstetrics & Gynecology (IDSOG) Virtual Annual Meeting.