FDA approves single-dose, oral bacterial vaginosis treatment

The first single-dose, oral treatment for bacterial vaginosis will be available by prescription in early 2018, 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.

The FDA approval was based on two trials in BV and an open-label safety study, which found that single-dose secnidazole 2 g was effective and generally well tolerated.

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

The first single-dose, oral treatment for bacterial vaginosis will be available by prescription in early 2018, 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.

The FDA approval was based on two trials in BV and an open-label safety study, which found that single-dose secnidazole 2 g was effective and generally well tolerated.

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

The first single-dose, oral treatment for bacterial vaginosis will be available by prescription in early 2018, 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.

The FDA approval was based on two trials in BV and an open-label safety study, which found that single-dose secnidazole 2 g was effective and generally well tolerated.

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