Lupin presents Phase 3 data for Solosec in female trichomoniasis patients

Based on the data, Lupin will submit a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Solosec® for the treatment of trichomoniasis later this year. Solosec is only currently approved by the FDA to treat bacterial vaginosis (BV) in adult women.

The trial titled "A Phase 3, multi-center, prospective, randomized, placebo-controlled, delayed treatment, double-blind study to evaluate the effectiveness and safety of a single oral dose of 2 grams of secnidazole for the treatment of trichomoniasis in women," met its primary endpoint of microbiological cure at the test-of-cure (TOC) visit on study Day 6-12. The microbiological cure was defined as a negative trichomonas vaginalis culture (i.e., InPouch™ TV test negative for T vaginalis) in the modified Intent-To-Treat (mITT) population (all randomized subjects who were culture positive for T. vaginalis and negative for gonorrhea and chlamydia at baseline). In the trial, 92.2 pc of patients in the Solosec group (59/64) achieved the primary endpoint versus 1.5 pc (1/67) in the placebo group (p< 0.001). In the Per-Protocol population, the cure rate was 94.9 pc (56/59) for Solosec versus 1.7 pc (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.

"Trichomoniasis is the most common non-viral, STI that impacts an estimated 3-5 million people in the US," Gregory Kaufman, MD, Senior Vice President, Global Clinical and Medical Affairs, Specialty at Lupin said, adding, "We look forward to working with the FDA as we file for this new indication."