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FDA approves Metronidazole 1.3% gel for bacterial vaginosis
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Actavis and Valeant Pharmaceuticals International Inc. announced that the FDA has approved a new antibiotic gel to treat bacterial vaginosis, according to a news release.
“Valeant is pleased that another internal [research and development] compound has been approved by the FDA and will soon be available,” Tage Ramakrishna, MD, chief medical officer of Valeant, said in the release. “Metronidazole 1.3% gives health care providers and women a new, safe and effective treatment for bacterial vaginosis.”
Metronidazole 1.3% vaginal gel is indicated for treatment of bacterial vaginosis in nonpregnant women, administered as a single dose intravaginally at bedtime.
The approval was based on the results of a phase 3, randomized, double blind, placebo-controlled trial, which demonstrated that the gel was safe, efficacious and well tolerated in women, according to Actavis. The most common adverse events included vulvovaginal candidiasis, vulvovaginal pruritis, headache, nausea, diarrhea and dysmenorrhea.
Actavis acquired the rights to Metronidazole 1.3% from Valeant in April 2013. The product is expected to be launched later this year.
“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 [bacterial vaginosis],” said Fred Wilkinson, president of global research and development at Actavis.