Melbourne, Australia; Starpharma today announced that it has received final written agreement from the FDA on the design of its Phase 3 clinical studies of VivaGel^® for the treatment of bacterial vaginosis (BV) under the FDA’s Special Protocol Assessment (SPA) scheme.

The SPA is a binding declaration from the FDA that the Phase 3 clinical study design, endpoints, statistical analyses, and other aspects of the planned studies are acceptable to support regulatory approval of the product.

“Receiving this SPA agreement gives Starpharma great confidence in our Phase 3 program, and allows us to proceed through this final development stage with a high level of clarity about the approval pathway for VivaGel^® for treatment of BV,” said Dr Jackie Fairley, Chief Executive Officer of Starpharma.

“It was pleasing to have received binding agreement so rapidly and without the need for further discussion with the Agency,” she said.

As previously announced, the company plans to commence its Phase 3 BV treatment program early in 2012 with completion expected before year end.  Following the completion of Phase 3 trials, the company plans to partner the product.

“Following our recent financing, we are also implementing various initiatives in collaboration with our CRO to expedite the trial timelines as much as possible,” added Dr Fairley.

These two Phase 3 studies will be conducted in parallel and the design – now agreed with both the FDA and EMA – is extremely similar to Starpharma’s successful Phase 2 trial of VivaGel^® for the treatment of BV.  

Download ASX Announcement: SPL receives FDA Special Protocol Assessment for BV Phase 3 (pdf file, 78kb)