FDA OK's High-Dose Metronidazole Vaginal Gel
Actavis and Valeant announced that the FDA has approved Metronidazole 1.3% Vaginal Gel for the treatment of bacterial vaginosis. In April 2013, Actavis acquired the rights to Metronidazole 1.3% from Valeant.
Metronidazole, a nitroimidazole antimicrobial, is reduced by metabolically active anaerobes. Studies have demonstrated that this reduced form of the drug interacts with bacterial DNA. The exact intracellular targets of action of metronidazole on anaerobes are unknown.
The FDA approval was based on the results of a Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial, which found that the higher concentration Metronidazole 1.3% was well tolerated, safe, and efficacious.
Metronidazole Vaginal Gel 1.3% will be available as a single-dose packaged in a prefilled disposable applicator. The product is expected launch later this year.
For more information call (800) 272-5525 or visit Actavis.com.