FDA Approves Solosec for Treatment of Bacterial Vaginosis

The US Food and Drug Administration (FDA) has approved secnidazole (Solosec) for the treatment of bacterial vaginosis (BV) in adult women, announced Symbiomix Therapeutics.

The next-generation, 2g, 5-nitroimidazole antibiotic offering enhanced pharmacokinetic properties, has shown to be efficacious and well tolerated. Solosec, designed to deliver an effective, single-dose oral treatment option, can be taken any point throughout the day, with or without a meal. It's clinically proven to normalize BV symptoms, odor and discharge, without the use of creams or week-long oral regimens.

"The approval of Solosec finally gives women the option of a single, well-tolerated, oral dose treatment for BV, a common infection which can have many health consequences," said Paul Nyirjesy, MD, professor of obstetrics and gynecology, Drexel University College of Medicine, investigator in Solosec clinical trials. "A single dose regimen may improve adherence and the likelihood of a successful cure."

BV, the most common gynecologic infection in the US, affects 21 million women aged 14—49 annually.

The FDA designated Solosec as a Qualified Infectious Disease Product (QIDP) for the treatment of BV, granting it fast track designation. Solosec was eligible for priority review and at least 10 years of United States market exclusivity.

Recent studies show more than 50% of women treated for the infection have recurrence within 12 months, and 60% of recurrent sufferers report a negative impact on work attendance, job performance and productivity, with 95% reporting a severe restriction in intimate partner relations.

The FDA approval, supported by comprehensive studies, includes 2 pivotal trials and an open label safety study with findings proving the efficacy for the single-dose 2g drug.

In clinical studies, the most common adverse events occurring in less than 2% of patients receiving Solosec 2g oral granules were vulvovaginal candidiasis, 9.6%, headache, 3.6%, nausea, 3.6%, dysgeusia, 3.4%, vomiting, 2.5%, diarrhea, 2.5%, abdominal pain, 2%, and vulvovaginal pruritus, 2%.

All treatment-emergent adverse effects were mild or moderate in intensity. There were no adverse effects reported and no patients discontinued treatment due to the effects.