Mumbai, Aug 14 (UNI) Pharma major Lupin Pharmaceuticals Inc the US based wholly owned subsidiary of Lupin Limited on Saturday announced results from its pivotal Phase 3 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 US.
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 data were presented at the 2020 Infectious Diseases Society for Obstetrics & Gynecology (IDSOG) Virtual Annual Meeting.
“The efficacy results of the Phase 3 study are quite encouraging and could support the utility of Solosec® in clinical practice as a treatment option for trichomoniasis once the new indication is approved,” said Christina Muzny, MD, MSPH, University of Alabama at Birmingham, who presented the abstract at IDSOG.
“Trichomoniasis increases risk of HIV infection, disproportionately affects African American women and can lead to adverse health outcomes. It is critical to screen women at high risk and treat with therapy that is convenient to use, to help improve patient compliance.”
Based on the data, Lupin will submit a supplemental New Drug Application (sNDA) to the US 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.
The trial titled “A Phase 3, 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 pc of patients in the Solosec group (59/64) achieved the primary endpoint versus 1.5 pc (1/67) in the placebo group (p< 0.001). In the Per-Protocol population, the cure rate was 94.9 pc (56/59) for Solosec versus 1.7 pc (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.
“Trichomoniasis is the most common non-viral, STI that impacts an estimated 3-5 million people in the US,” Gregory Kaufman, MD, Senior Vice President, Global Clinical and Medical Affairs, Specialty at Lupin said, adding, “We look forward to working with the FDA as we file for this new indication.”
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