VivaGel® for Bacterial Vaginosis
VivaGel® has been developed for the treatment of BV and prevention of recurrent 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 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 trials of VivaGel® BV for the prevention of recurrent BV achieved their primary objective demonstrating statistically significant superiority compared to placebo in preventing the recurrence of BV.
The phase 3 trial results for both the treatment of BV (2012) and the prevention of recurrent BV (2017) strongly support marketing applications for VivaGel® BV to the US FDA and other regulators. The New Drug Application (NDA) for VivaGel® BV incorporating both BV indications has been completed and submitted to the FDA under Fast Track status.
The FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for VivaGel® BV (for both BV indications). 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 also has a Special Protocol Agreement (SPA) in place from the FDA for VivaGel® BV which provides binding FDA agreement on the phase 3 trial design for prevention of recurrent BV.
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 US$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.