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Positive Pivotal Data Reported for Secnidazole in Bacterial Vaginosis
Positive results have been reported from the second pivotal trial of secnidazole (SYM-1219) for the treatment of women with bacterial vaginosis (BV). SYM-1219 is a next-generation 5-nitroimidazole antibiotic intended for single-dose oral treatment of BV.
The drug’s developer (Symbiomix) also announced a successful meeting with the FDA to discuss the requirements for a new drug application (NDA) filing for secnidazole in the fourth quarter of 2016.
The second pivotal trial of secnidazole was a phase 3, randomized, double-blind, placebo-controlled study that compared a single oral dose of secnidazole with placebo in 189 women with either infrequent infections or recurrent BV. Secnidazole achieved statistically and clinically significant results across all primary and secondary endpoints.
If approved, secnidazole would be the first single-dose oral therapy for BV. Because of its single-dose oral regimen, secnidazole is expected to provide better adherence to treatment compared with the current standard of care. Adherence with the current leading therapy for the treatment of BV is only approximately 50%. Further, poor adherence to anti-infective therapy can lead to treatment failures, recurrent disease, and the more-rapid development of resistant microorganisms. These, in turn, may lead to higher health care costs, including increased out-of-pocket expenses, increased office visits and tests, additional treatment costs, and lost productivity.
BV is the most common gynecological infection in the U.S. among women 15 to 44 years of age. More than four million women are treated in the United States for BV annually. Of these women, more than 50% have a recurrence within 12 months.
The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks, including the following:
- Increasing the risk of human immunodeficiency virus (HIV) transmission from an HIV-infected partner
- Increasing the risk of HIV transmission to an HIV-uninfected partner
- In pregnant women, increasing the risk of delivering a baby too early
- Increasing the risk of contracting sexually transmitted diseases, such as chlamydia and gonorrhea, which, if untreated, may lead to pelvic inflammatory disease and infertility
Source: Symbiomix; May 26, 2016.