Lupin’s arm declares positive topline results from Phase 3 Study of Single-Dose Solosec

05 May 2020 Evaluate

Lupin’s US based wholly owned subsidiary -- Lupin Pharmaceuticals Inc has declared 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 US. 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, the company plans to submit a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (USFDA) for Solosec for the treatment of trichomoniasis in the second half of 2020. Solosec is approved by the USFDA to treat bacterial vaginosis (BV) in adult women.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

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