The US Food and Drug Administration (FDA) has approved Actavis-Valeant’s new drug application (NDA) for Metronidazole 1.3% vaginal gel, an antibiotic for treatment of bacterial vaginosis (BV).

Approval was based on the results from a randomised, double-blind, placebo-controlled, multicentre Phase III study, which found that the higher concentration Metronidazole 1.3% was well-tolerated, safe and efficacious.

The company said that metronidazole 1.3% provides an alternative treatment option to MetroGel-Vaginal (metronidazole vaginal gel 0.75%) for patients with BV.

Common adverse reactions observed in the clinical trial were vulvovaginal candidiasis, headache, vulvovaginal pruritus, nausea, diarrhoea, and dysmenorrhea.

In April 2013, Valeant awarded Actavis the rights of Metronidazole 1.3%, which provides a convenient, single-dose treatment for BV.

The disease is caused by an imbalance in the normal bacteria in the vagina and is the most common vaginal infection in women aged 15 to 44.

Actavis Global R&D president Fred Wilkinson said the approval of Metronidazole 1.3% is a significant milestone for the company and provides an important new option with a single-dose treatment for women suffering from BV.

“Metronidazole 1.3% gives health care providers and women a new safe and effective treatment for bacterial vaginosis.”

“The expected launch of the product later this year will establish a promising long-term opportunity for Actavis and support the continued growth of our industry-leading Women’s Health franchise,” Wilkinson said.

Under the deal with Valeant, Actavis will pay around $57m in upfront and milestone payments, as well as certain guaranteed royalty payments during the first three years of commercialisation, depending on market conditions.

Valeant is also eligible to receive ongoing royalties from Actavis following the first three years of commercialisation.

Valeant Pharmaceuticals chief medical officer Tage Ramakrishna said the company is happy that another internal R&D compound has been approved by the FDA and will soon be available.

“Metronidazole 1.3% gives health care providers and women a new safe and effective treatment for bacterial vaginosis,” Ramakrishna said.

Image: Microscopic view of Gardnerella vaginalis. Photo: courtesy of Dr FC Turner.