Solosec Approved for Treatment of Bacterial Vaginosis
Bacterial vaginosis is the most common gynecologic infection in the United States, affecting 21 million women between the ages of 14 and 49, each year.
Solosec (secnidazole) has been approved by the US Food and Drug Administration (FDA) for the treatment of bacterial vaginosis (BV) in adult women. BV is the most common gynecologic infection in the United States, affecting 21 million women between the ages of 14 and 49, each year.
The drug is administered as a single 2-gram packet of granules given once orally. Prescribing information indicates that women may sprinkle the entire contents of the packet onto applesauce, yogurt, or pudding and consume all of the mixture within 30 minutes without chewing or crunching the granules. A glass of water may be taken to aid in swallowing. The drug is not intended to be dissolved in any liquid.
Solosec is a next-generation, 2g, 5-nitroimidazole antibiotic offering enhanced pharmacokinetic properties. It can be taken any point throughout the day, with or without a meal. Clinical data has shown that Solosec has been efficacious in normalizing symptoms of BV, including odor and discharge, without the use of creams or week-long oral regimens.
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.
"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 in a press release. "A single dose regimen may improve adherence and the likelihood of a successful cure."