HCPLive Network

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.


Further Reading
The US Food and Drug Administration (FDA) approved Bexsero, a Novartis vaccine to prevent meningococcal disease caused by Neisseria meningitides serogroup B. It is meant for children age 10 and up and young adults through age 25.
The US Food and Drug Administration (FDA) approved secukinumab (Cosentyx/Novartis) for adults with moderate to severe plaque psoriasis. The European Commission approved the same drug on Jan. 19. Its active ingredient is an antibody that binds to interleukin-17A and interferes with inflammation. The binding prevents that protein from triggering the inflammatory response that results in psoriasis patches.
The US Food and Drug Administration today approved Merck’s Gardasil 9, a vaccine that offers protection against 5 more types of Human Papillomavirus (HPV) than original Gardasil. In addition to preventing cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18 (those prevented by the older version of Gardasil) Gardasil 9 also prevents those cancers caused by HPV strains 31, 33, 45, 52, and 58.
More Reading
$related2$