Company: Symbiomix Therapeutics
Approval Status: Approved September 2017
Specific Treatments: bacterial vaginosis
Solosec (secnidazole) is a nitroimidazole antimicrobial.
Solosec is specifically indicated for the treatment of bacterial vaginosis in adult women.
Solosec is supplied as oral granules. The recommended dosage of Solosec is a single 2-gram packet of granules taken once orally, without regard to the timing of meals. Open the Solosec packet by folding over the corner (marked by an arrow) and tearing across the top. Sprinkle the entire contents of the packet onto applesauce, yogurt or pudding. The granules will not dissolve. Consume all of the mixture within 30 minutes without chewing or crunching the granules. A glass of water may be taken after the administration of Solosec to aid in swallowing.The granules are not intended to be dissolved in any liquid.
The FDA approval of Solosec was based on Two randomized placebo-controlled clinical trials (Trial 1 and Trial 2) with similar designs were conducted to evaluate the efficacy of Solosec 2 gram for the treatment of bacterial vaginosis. Trial 1 enrolled 144 non-pregnant female patients aged 19 to 54 years and Trial 2 enrolled 189 non-pregnant females aged 18 to 54 years. Efficacy was assessed by clinical outcome evaluated 21 to 30 days following a single dose of Solosec. A Clinical responder was defined as “normal” vaginal discharge, negative “whiff” test, and clue cells <20%. In both trials, a statistically significantly greater percentage of patients experienced clinical response at 21 to 30 days following a single dose of Solosec compared to placebo: Trial 1: 67.7% vs. 17.7% and Trial 2: 53.3% vs. 19.3%. Statistically significant results for the endpoints were also achieved at Day 7-14 in Trial 2.
Adverse effects associated with the use of Solosec may include, but are not limited to, the following:
- vulvo-vaginal candidiasis
- abdominal pain
- vulvovaginal pruritus
Mechanism of Action
Solosec (secnidazole) is a 5-nitroimidazole antimicrobial. 5-nitroimidazoles enter the bacterial cell as an inactive prodrug where the nitro group is reduced by bacterial enzymes to radical anions. It is believed that these radical anions interfere with bacterial DNA synthesis of susceptible isolates.
For additional information regarding Solosec or bacterial vaginosis, please visit http://solosec.com/