Starpharma's Vivagel fast-tracked by FDA

Melbourne, Australia-based nanotechnology specialists Starpharma says that the US Food and Drug Administration has granted the company's drug Vivagel (SPL7013 gel), its vaginal microbicide against sexually-transmitted infections, fast-track designation.

The product, which is the first to emerge from the company's dendrimer-based discovery pipeline, was primarily developed to prevent the transmission of genital herpes and HIV in women. Additionally, the firm reports that it has recently been awarded $20.0 million from the USA's National Institutes of Health to expedite the drug's development.

Starpharma's chief executive, John Raff, said that there were no current products designed to prevent HIV and genital herpes infection, and that Vivagel, if granted full US approval, could cater for this unmet medical need. The firm expects the FDA's decision in the next six months.