Lupin Announces Positive Topline Results From its Phase 3 Study of Single-Dose Solosec® (secnidazole) in Trichomoniasis

Mumbai,Baltimore: Lupin Pharmaceuticals Inc. has announced positive top-line results from its pivotal Phase 3 clinical trial to assess efficacy and safety of single-dose Solosec® (secnidazole) 2g oral granules in 147 female patients with trichomoniasis.

Trichomoniasis is the most common non-viral, curable sexually transmitted infection (STI) in the U.S. The trial demonstrated a clinically and statistically significant response rate, or microbiological cure, in patients dosed with Solosec® as compared to placebo (p<0.001). Based on the data, Lupin plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Solosec® for the treatment of trichomoniasis in the second half of 2020.

Solosec® is approved by the FDA to treat bacterial vaginosis (BV) in adult women.

The trial met its primary endpoint of microbiological cure at the test-of-cure (TOC) visit on study day 6-12, defined as a negative Trichomonas vaginalis culture. The predefined primary efficacy endpoint, defined as Microbiological Cure (i.e., InPouch™ TV test negative for T. vaginalis) at the Test-Of-Cure visit (Day 6-12) 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), was 92.2% (59/64) for Solosec® (secnidazole) versus 1.5% (1/67) for placebo ( p<0.001).