, thanks to its approval by the Food and Drug Administration.
Symbiomix Therapeutics announced Sept. 18 that the FDA had granted approval to secnidazole (Solosec) 2 g oral granules for the treatment of bacterial vaginosis in adult women. Clinical trials of the 5-nitroimidazole antibiotic have shown it to be effective in a single dose, offering the potential for greater patient adherence to treatment over the common regimen of twice-a-day dosing for 7 days.
In a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study of 215 women with bacterial vaginosis, the clinical cure rate was 65.3% for the 2-g secnidazole group, 49.3% for the 1-g secnidazole group, and 19.4% for the placebo group (Obstet Gynecol. 2017 Aug;130[2]:379-86).
Similarly, in a phase 3 double-blind, placebo-controlled study with 189 women, clinical cure rates based on the 2016 FDA guidance were 64.0% for single-dose secnidazole 2 g versus 26.4% for placebo (Am J Obstet Gynecol. 2017 Sep 1. doi: 10.1016/j.ajog.2017.08.017).
The most common adverse events in the trials were vulvovaginal candidiasis (9.6%), headache (3.6%), nausea (3.6%), dysgeusia (3.4%), vomiting (2.5%), diarrhea (2.5%), abdominal pain (2.0%), and vulvovaginal pruritus (2.0%).
The FDA designated the drug as a qualified infectious disease product and granted it fast-track designation, making it eligible for priority review and at least 10 years of market exclusivity.
mschneider@frontlinemedcom.com
On Twitter @maryellenny