VivaGel® is being developed to provide symptomatic relief, and to prevent recurrence of, bacterial vaginosis (BV). BV is caused by an imbalance of the normal vaginal bacterial microflora, with healthy bacteria (e.g. Lactobacillus species) being depleted and harmful bacteria (e.g. Gardnerella vaginalis) overly abundant.
VivaGel® formulated as a mucoadhesive gel (VivaGel® BV) has been approved for marketing in the European Union as a 7-day therapy for the topical treatment and rapid relief of BV including its symptoms. VivaGel® BV has been shown to have efficacy for treatment of BV in a Phase 2 clinical study and was shown to achieve statistically significant cure of the signs and symptoms of BV at the end of treatment in two Phase 3 studies.
Phase 3 clinical studies of VivaGel® BV are ongoing to confirm the effectiveness of the product in preventing recurrence of BV.
The US FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the VivaGel® BV treatment and prevention indications for BV. These designations recognise the high unmet medical need in the management of BV and are designed to make new products available to patients as rapidly as possible. The benefits of QIDP and Fast Track are highly advantageous and include: priority regulatory review, an additional five years’ of market exclusivity, more frequent interactions with the FDA and expedited review, leading to faster approval.
Starpharma has commenced compiling a VivaGel® BV marketing application for submission to the FDA. It is expected that an application will be made in the near future for the treatment of BV, with the prevention indication to follow.
The current market for the management of BV and associated symptoms is estimated to be in excess of US$750 million globally, with significant areas of unmet need for BV sufferers. Starpharma’s modelling suggests the addressable global market for prevention of recurrence of BV is potentially in excess of $1 billion.
Throughout the world, BV is the most common vaginal infection. For example in the US, an estimated 21 million women aged 14-49 years (approximately 29%) are infected with BV. BV leads to symptoms including abnormal vaginal discharge and odour that are unpleasant and disrupt and interfere with a woman’s relationships and general quality of life.
It is commonly recognised that the existing therapeutic options for BV 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.