FDA Approval: Single-Dose Oral Therapy for Bacterial Vaginosis
Solosec may be co-administered with combination oral contraceptives as no clinically significant drug interaction was seen. Photo Credit: CDC/M Rein.
The Food and Drug Administration (FDA) has approved Solosec (secnidazole; Symbiomix Therapeutics) for the treatment of bacterial vaginosis in adult women, making it the first single-dose oral therapy for this indication.
The approval was based on 2 randomized, placebo-controlled studies which evaluated the efficacy of Solosec in the treatment of bacterial vaginosis. Efficacy was assessed by clinical outcomes evaluated 21 to 30 days following a single dose of Solosec. A clinical responder was defined as having "normal" vaginal discharge, negative "whiff" test, and clue cells <20%; additional endpoints included Nugent score cure and therapeutic outcome.
In both trials, a statistically significantly greater percentage of patients experienced clinical response (Trial 1 (n=144): 67.7% vs 17.7%; Trial 2 (n=189): 53.3% vs 19.3%), Nugent score cure (Trial 1: 40.3% vs 6.5%; Trial 2: 43.9% vs 5.3%), and therapeutic response (Trial 1: 40.3% vs 6.5%; Trial 2: 34.6% vs 3.5%) at 21 to 30 days following a single dose of Solosec compared to placebo.
Solosec, a nitroimidazole antimicrobial drug, is supplied as oral granules in single 2-gram packets. The granules can be sprinkled onto applesauce, yogurt or pudding, however they do not dissolve and are not intended to be dissolved in any liquid. To help with swallowing, a glass of water may be consumed after administration.
Per the drug labeling, Solosec may be co-administered with combination oral contraceptives as no clinically significant drug interaction was seen between secnidazole and ethinyl estradiol plus norethindrone.
Solosec has been designated as a Qualified Infectious Disease Product for bacterial vaginosis and was granted Fast Track status by the FDA. The product is expected to be available in the first quarter of 2018.
FDA approves Symbiomix Therapeutics' Solosec™ (secnidazole) oral granules for the treatment of bacterial vaginosis in adult women [press release]. Newark, New Jersey: Symbiomix. Published September 18, 2017. Accessed September 25, 2017.