On March 25, 2014 Actavis and Valeant Pharmaceuticals announced the FDA approval of Metronidazole 1.3% gel for the antibiotic treatment of Bacterial Vaginosis. Bacterial Vaginosis, or BV, is an extremely common vaginal infection which commonly affects women between the ages of 15 and 44. An imbalance of normal bacteria in the vagina is the leading cause of BV. The approval of Metronidazole 1.3% gel is a financial boon for Actavis and Valeant Pharmaceuticals, as the Bacterial Vaginosis treatment market is valued at $140 million annually.
Metronidazole 1.3% gel is now available to women as an easy to use pre-filled disposable applicator. The convenience, as well as efficacy and tolerability of Metronidazole 1.3% gel makes this newly approved treatment for BV significant for the pharmaceutical industry. The safety profile of Metronidazole 1.3% gel was apparent, with very few patients experiencing negative side effects during trials. Common complaints included minor vulvovaginal candidiasis, nausea and headache. Untreated Bacterial Vaginosis can lead to fertility issues, a heightened risk for sexually transmitted diseases and a serious pelvic infection or pelvic inflammatory disease. Antibiotic medications, such as an efficacious gel like Metronidazole, will help ensure that women affected with this regularly diagnosed condition will have proper and timely treatment.
The approval of the 1.3% gel was based on the successful results from a Phase III double-blind, placebo-controlled, randomized and multicenter trial. The higher dosage of Metronidazole proved to be well tolerated and a more effective option for some cases of BV when compared to MetroGel-Vaginal, also known as Metronidazole 0.75% gel. Certain cases of Bacterial Vaginosis require a higher strength treatment with Metronidazole, and the 1.3% gel offers this option.
LGM Pharma provides the API Metronidazole CAS# 443-48-1 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.
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