24 September 2015 - Starpharma today announced it has received, overnight, marketing approval in the European Union (EU) for VivaGel BV for the treatment and rapid relief of bacterial vaginosis (BV) including symptoms.

The approval allows for the marketing of VivaGel BV in the European Economic Area (EEA), which includes the 28 countries of the EU plus the European Free Trade Association (EFTA) countries, providing access to a population of more than 260 million women. In addition, the EU approval will be used as the basis for obtaining what is expected to be relatively rapid regulatory and marketing approvals for VivaGel BV in a number of other countries that formally recognise the EU approval.

Bacterial vaginosis is the most common vaginal infection worldwide. It is the most common cause of abnormal vaginal discharge and unpleasant vaginal odour in women and is associated with an increased risk of pre-term births, miscarriage, and transmission and acquisition of STIs, including genital herpes and HIV/AIDS.

In clinical trials, VivaGel BV, when used once daily for seven days, demonstrated significant benefits over a placebo in the treatment of BV in women. A key benefit of VivaGel BV in clinical trials was the rapid relief of patients’ symptoms associated with BV, including unpleasant vaginal odour and discharge. In addition, use of VivaGel BV helped to normalise vaginal pH and suppress the bacteria that cause the vaginal microflora imbalance that characterises BV. In formal market research BV sufferers using VivaGel BV reported very high levels of overall satisfaction, comfort and ease of use.

For more details, go to: http://www.starpharma.com/news/253