Infectious Disease

FDA Approves Complementary NDA for Secnidazole for the Treatment of Trichomoniasis

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Stelzmiller works for Lupine Pharmaceuticals. Healio was unable to confirm any relevant financial information for Chavoustie at the time of publication.

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The FDA this week approved an additional application for a new drug to expand the use of secnidazole to treat trichomoniasis in adults.

“The FDA approval for the additional indication for Solosec (Secnidazole, Lupine Pharmaceuticals) for the treatment of trichomoniasis builds on our commitment to supporting women’s health and offers healthcare professionals an option to treat patients with trichomoniasis and bacterial vaginosis (BV), Jon Stelzmiller, who heads the specialties business at Lupine Pharmaceuticals, said in a press release announcing the approval.

FDA approved

The FDA has approved Lupine Pharmaceuticals’ supplemental NDA to expand the use of secnidazole to treat trichomoniasis in adults. Source: Adobe Stock.

“Also, a treatment option for trichomoniasis and BV that provides a full course of therapy in a single dose will help bridge adherence-related care gaps and therefore reduce risk factors associated with trichomoniasis or BV such as pelvic inflammation (PID) and others sexually communicable infections, ”said Stelzmiller.

Approval was based on results from the Phase 3 clinical trial, which found clinically and statistically significant cure rates of 92.2% in patients with trichomoniasis treated with secnidazole (n = 64) compared to placebo (p <0.001) modified intent-to-treat. method showed population and 94.9% in the per-protocol population. The study also showed that cure rates were 100% in women with HIV and 95.2% in women with BV.

“Trichomoniasis is a very common STI that can increase a person’s risk of contracting or spreading other STIs, including HIV,” said Steven Chavoustie, MD, FACOG, CCRP, obstetrician and gynecologist at the Segal Institute for Clinical Research, in the Press release. If left untreated, trichomoniasis can persist for months or years and cause negative effects on reproductive health, including infertility and premature birth. For these reasons, screening and treatment for trichomoniasis is critical, and I am delighted that there is a new treatment option that can help meet the needs of this patient population. “

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