Starpharma has received final written agreement from the FDA on the design of its Phase III studies of VivaGel for the treatment of bacterial vaginosis (BV) under the FDA's SPA scheme. The latter is a binding declaration from the FDA that the study design, endpoints, statistical analyses and other aspects of the planned studies are acceptable to support regulatory approval of the product.
The company plans to begin its Phase III BV treatment programme early in 2012 with completion expected before year-end. Following the completion of these trials, Starpharma plans to find a partner for the product.
VivaGel contains an antimicrobial agent, which is being applied to a range of sexual health products in development by Starpharma and its partners, including VivaGel-coated condom, VivaGel for the prevention of sexually transmitted infections and VivaGel for the treatment and prevention of BV. The active ingredient of VivaGel is the dendrimer, SPL7013, which has been shown in scientific studies to inhibit infection with viruses, including HIV and genital herpes, and the growth of bacteria.