Lupin announced positive topline data from a phase 3 study evaluating secnidazole for the treatment of trichomoniasis.
The multicenter, double-blind, placebo-controlled study investigated the efficacy and safety of secnidazole in 147 adult females with trichomoniasis. Patients were randomized to receive either a 2g single oral dose of secnidazole granules or placebo at visit 1 (baseline). After 6-12 days, patients were evaluated at the “test of cure” (TOC) visit. The primary end point was microbiological cure at the TOC visit.
Findings from the study showed that treatment with secnidazole resulted in statistically significant microbiological cure, defined as a negative Trichomonas vaginalis culture, compared with placebo at the TOC visit (P <.001). The cure rate was 92.2% (n=59/64) for secnidazole compared with 1.5% (n=1/67) for placebo in the modified intent-to-treat population, which included patients who tested positive for T. vaginalis and negative for gonorrhea and chlamydia at baseline.
With regard to safety, secnidazole was generally well tolerated. The most common adverse events included vulvovaginal candidiasis (2.7%) and nausea (2.7%). There were no serious adverse events observed.
The Company plans to submit a supplemental New Drug Application for secnidazole to the Food and Drug Administration in the second half of 2020.
“We are encouraged by the topline results of our clinical trial, look forward to finalizing the analysis, and working with the FDA to provide a new single-dose therapy option to physicians and patients, to treat this disease,” said Gregory Kaufman, MD, Senior Vice President, Global Clinical and Medical Affairs, Specialty at Lupin.
Secnidazole is marketed under the trade name Solosec® and is currently approved for the treatment of bacterial vaginosis in adult women. The product is supplied as oral granules in single 2g unit-of-use, child-resistant packets.
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