Lupin's supplemental new drug application for Solosec accepted by USFDA

"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 data were presented at the 2020 Infectious Diseases Society for Obstetrics & Gynecology (IDSOG) Virtual Annual Meeting.