Actavis and Valeant Pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has approved Metronidazole 1.3% Vaginal Gel. The approved New Drug Application (NDA) is for an antibiotic to treat bacterial vaginosis (BV). Valeant sold rights to the drug to Actavis in April of 2013. The agreement consists of upfront payments, milestone payments, and royalty payments. Fred Wilkinson, Actavis President of Global R&D said, "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.” Actavis plans to launch the product later this year.
Bacterial vaginosis (BV) is an infection caused by a bacterial imbalance in the vagina. The condition is common in women ages 15 to 44 years of age. The cause of the bacterial imbalance is not conclusively known. However, certain behaviors make infection more likely. Multiple sex partners, new sex partners, and douching increases the likelihood of getting BV. The infection is not a sexually transmitted disease (STD), although the Centers for Disease Control (CDC) lists it as one because imbalanced bacteria can increase the risk for STDs.
Metronidazole is a nitroimidazole antimicrobial for anaerobic and protozoal infections. It kills bacteria with toxic metabolites that break DNA strands. The agent rarely shows clinical and microbiological resistance. Oral availability is almost complete with about 90 percent absorption. Given vaginally as Metronidazole 1.3% is administered, the agent has between 20 to 56 percent bioavailability. The drug is packaged in a pre-filled applicator that is disposed of after use. Patients self-administer intra-vaginally at bedtime.
The FDA approved Metronidazole 1.3% after reviewing the results of a Phase III clinical trial. The multi-center, placebo-controlled trial found that patients tolerated the drug without difficulty and the dose was effective and safe. The FDA found that Metronidazole 1.3% provides a safe and effective alternative to MetroGel-Vaginal (metronidazole vaginal gel 0.75%).
Actavis plc is headquartered in Dublin, has U.S. headquarters in Parsippany, NJ, and operates in over 60 countries. The company focuses on the development and distribution of branded drugs and generic bio-equivalents. Therapeutic categories include women’s health, dermatology, gastroenterology, oncology, and urology.