Phase III clinical trial of Solosec shows efficacy in trichomoniasis STI.- Lupin Pharma

Lupin Pharmaceuticals announced results from its pivotal Phase III clinical trial to assess efficacy and safety of single-dose Solosec (secnidazole) 2g oral granules in female patients with trichomoniasis, the most common non-viral, curable sexually transmitted infection (STI) in the U.S. The trial results showed a clinically and statistically significant response rate, or microbiological cure, in patients treated with Solosec as compared to placebo (p<0.001). the trial titled "a phase iii, 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. 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% of patients in the solosec group (59 64) achieved the primary endpoint versus 1.5% (1 67) in the placebo group (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. based on the data, lupin will submit a supplemental new drug application (snda) to the u.s. 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.>