The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for secnidazole (Lupin Pharmaceuticals) for the treatment of trichomoniasis.
The sNDA is based on data from a double-blind, placebo-controlled phase 3 study that evaluated the efficacy and safety of secnidazole, a nitroimidazole antimicrobial drug, in 147 adult female patients with trichomoniasis. Patients were randomized to receive either a 2g single oral dose of secnidazole granules or placebo at visit 1 (baseline). After 6 to 12 days, patients were evaluated at the “test of cure” (TOC) visit. The primary end point was microbiological cure at the TOC visit.
Results showed that treatment with secnidazole resulted in clinically and statistically significant microbiological cure, defined as a negative Trichomonas vaginalis culture, vs placebo at the TOC visit (P <.001). The cure rate was 92.2% (n=59/64) for secnidazole vs 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. Additionally, in the per-protocol population, the cure rate was 94.9% (n=56/59) for secnidazole vs 1.7% (n=1/60) for placebo (P <.001).
As for safety, secnidazole was generally well tolerated with the most common adverse events being vulvovaginal candidiasis (2.7%) and nausea (2.7%). There were no serious adverse events observed.
A Prescription Drug User Fee Act (PDUFA) target date of June 30, 2021 has been set for this application.
Secnidazole is marketed under the brand 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.
For more information visit lupin.com.
Lupin announces FDA filing acceptance of supplemental New Drug Application for Solosec® (secnidazole) for the treatment of trichomoniasis. [press release]. Mumbai, India and Baltimore, MD: Lupin Pharmaceuticals, Inc; November 16, 2020.