FDA Approves Alternative Gel Treatment for Bacterial Vaginosis

The US Food and Drug Administration (FDA) has approved a new antibiotic treatment for bacterial vaginosis (BV), announced the drug’s joint manufacturers, Activis and Valeant Pharmaceuticals.

Metronidazole 1.3% is a single-dose treatment for BV, which is the most common vaginal infection for women aged 15-44 years. The pre-filled disposable applicator should be administered once intravaginally at bedtime, according to the drug’s label.

“The approval of Metronidazole 1.3% is a significant milestone for Actavis and provides an important new option with a single-dose treatment for women suffering from BV,” Fred Wilkinson, President of Actavis Global R&D, said in a statement.

The FDA approved Metronidazole 1.3% after reviewing the results of a phase 3 multicenter trial that showed the higher concentration of the vaginal gel was well-tolerated, safe, and efficacious. It is an alternative treatment to the existing BV treatment, MetroGel-Vaginal (metronidazole vaginal gel 0.75%), the manufacturers noted.

“Metronidazole 1.3% gives healthcare providers and women a new safe and effective treatment for BV,” Tage Ramakrishna, MD and Chief Medical Officer of Valeant Pharmaceuticals, added in the statement.

Metronidazole 1.3% is indicated for non-pregnant women. In the drug’s late-stage trial, reported side effects included vulvovaginal candidiasis, headache, vulvovaginal pruritus, nausea, diarrhea, and dysmenorrhea.