VivaGel BV receives EU approval for bacterial vaginosis-Starpharma

Starpharma has received marketing approval in the European Union for VivaGel BV for the treatment and rapid relief of bacterial vaginosis including symptoms. The approval allows for the marketing of VivaGel BV in the European Economic Area. 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. 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. The phase III clinical trial programme is also progressing in North America and Asia.

Comment: It is commonly recognised that the existing therapeutic options for Bacterial Vaginosis are inadequate because of low cure rates, high rates of recurrence, potentially severe systemic adverse effects and, for some products, incompatibility with alcohol consumption or condoms. Existing antibiotic approaches are not considered suitable for long-term maintenance therapy. In contrast, VivaGel is well tolerated, is not absorbed (and so is free from systemic effects), can be used with condoms, and is therefore an ideal maintenance therapy to prevent recurrence of BV.